Described herein are compositions and methods for identifying, selecting, or culturing cells comprising a subject nucleic acid sequence of interest. Generally, a nucleic acid comprising a subject nucleic acid and a sequence encoding an enzyme molecule involved in biosynthesis of an amino acid is introduced into a cell. The cell is then grown on media lacking the amino acid, such that cells comprising the introduced nucleic acid are capable of growth. In some instances, the cell further comprises an inhibitor of the enzyme molecule to increase the stringency of the selection.
C07B 37/00 - Reactions without formation or introduction of functional groups containing hetero atoms, involving either the formation of a carbon-to-carbon bond between two carbon atoms not directly linked already or the disconnection of two directly linked carbon atoms
C07D 207/277 - Carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals
C07D 211/70 - Heterocyclic compounds containing hydrogenated pyridine rings, not condensed with other rings with only hydrogen or carbon atoms directly attached to the ring nitrogen atom having one double bond between ring members or between a ring member and a non-ring member with only hydrogen atoms, hydrocarbon or substituted hydrocarbon radicals, directly attached to ring carbon atoms
C07C 17/16 - Preparation of halogenated hydrocarbons by replacement by halogens of hydroxyl groups
C07C 17/18 - Preparation of halogenated hydrocarbons by replacement by halogens of oxygen atoms of carbonyl groups
C07C 41/22 - Preparation of ethers by reactions not forming ether-oxygen bonds by introduction of halogenPreparation of ethers by reactions not forming ether-oxygen bonds by substitution of halogen atoms by other halogen atoms
C07C 51/60 - Preparation of carboxylic acid halides by conversion of carboxylic acids or their anhydrides into halides with the same carboxylic acid part
C07C 67/287 - Preparation of carboxylic acid esters by modifying the hydroxylic moiety of the ester, such modification not being an introduction of an ester group by introduction of halogenPreparation of carboxylic acid esters by modifying the hydroxylic moiety of the ester, such modification not being an introduction of an ester group by substitution of halogen atoms by other halogen atoms
C07C 67/307 - Preparation of carboxylic acid esters by modifying the acid moiety of the ester, such modification not being an introduction of an ester group by introduction of halogenPreparation of carboxylic acid esters by modifying the acid moiety of the ester, such modification not being an introduction of an ester group by substitution of halogen atoms by other halogen atoms
Provided are compositions comprising a population of cells that are amenable to freezing or lyophilization while maintaining viable cells. The compositions comprise a monosaccharide, urea and, in some embodiments, a bulking agent. Also provided are methods for preparing and storing cells via freezing or lyophilization in a manner that allows cells to remain viable during storage.
The present disclosure is directed to the organic growth and phasing design for a system for the industrial growth of biologics. A system may include a number of subsystems, such as a buffer distribution subsystem, a media preparation subsystem, a bioreactor subsystem, a harvest subsystem, and/or a purification subsystem. The subsystems may be highly interconnected for flexible process flow design. Additionally, the subsystems may be constructed with a total output capacity with a total number of equipment stations and operated at a lower output capacity with fewer than the total equipment stations to maintain headroom for growth in phases.
A eukaryotic host cell which is engineered to introduce a recombinant expression cassette expressing a gene of interest (GOI) to produce a protein of interest (POI), and by a genetic modification to control expression of a Pat1 protein.
The present invention is in the field of recombinant biotechnology, in particular in the field of protein expression. The invention generally relates to a method of increasing the yield and/or titer of at least one protein of interest in a eukaryotic host cell, preferably a yeast, comprising overexpressing in said host cell a) at least one polynucleotide encoding at least one Sbh1 transport protein, and b) (i) at least one polynucleotide encoding at least one Kar2 endoplasmic reticulum helper protein; or (ii) at least one polynucleotide encoding at least one Hac1 transcription factor. The invention further relates to a recombinant eukaryotic host cell for manufacturing at least one protein of interest, which is engineered to overexpress at least one polynucleotide encoding said at least one Sbh1 transport protein, and b) (i) at least one polynucleotide encoding said at least one Kar2 endoplasmic reticulum helper protein; or (ii) at least one polynucleotide encoding said at least one Hac1 transcription factor as well as the use of said recombinant eukaryotic host cell for manufacturing at least one protein of interest.
The present invention refers to a method for providing a computer-implemented neural network configured for predicting a concentration-dependent viscosity of a protein solution. Further, the present invention refers to methods for predicting a concentration-dependent viscosity of a protein solution, for determining a concentration-dependent viscosity of a protein solution, and for providing a drug product comprising a protein solution, by using such a computer-implemented neural network.
The present disclosure provides an ultraviolet light filter for use in photostability testing chambers, and in particular, filters that are designed to allow for air ventilation and maintenance of desired temperatures at the sample level during light exposure testing.
The present invention relates to a nucleic acid molecule encoding a fusion protein comprising a secretion signal comprising (i) a signal peptide sequence originating from a KRE1 protein or a signal peptide sequence originating from a SWP1 protein; and optionally (ii) an α-mating factor (MFα) pro-sequence, and a protein of interest. The present invention further relates to a secretion signal as defined herein, an expression cassette comprising said nucleic acid molecule as well as recombinant eukaryotic host cells comprising said nucleic acid molecule or expression cassette. Further encompassed is a method of manufacturing a protein of interest in a eukaryotic host cell and a method of increasing the secretion of a protein of interest from a eukaryotic host cell. Further provided is the use of the secretion signal for increasing the secretion of a recombinant protein of interest from a eukaryotic host cell and the use of the recombinant host cell for manufacturing a recombinant protein of interest.
A method for delivering a processing solution includes providing a concentrated processing solution in a bioprocess container, the concentrated processing solution being produced at a first site. The method also includes combining the concentrated processing solution with a biopolymer containing solution produced in a bioreactor at a second site different from the first site. In some embodiments, the processing solution is a buffer for processing products of cells cultured in a bioreactor. A system and a pharmaceutical production facility for carrying out the method is also provided.
01 - Chemical and biological materials for industrial, scientific and agricultural use
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
(1) Préparations biologiques, à savoir cellules et vecteurs génétiquement modifiés pour la production de protéines humaines, animales et synthétiques, pour l¿usage dans la recherche scientifique, dans la recherche pharmaceutique et pour l'usage clinique et commercial.
(2) Préparations biologiques, à savoir cellules génétiquement modifiés et vecteurs génétiquement modifiés pour la production de protéines humaines, animales et synthétiques, pour l'usage clinique et commercial en thérapeutique humaine et animale.
01 - Chemical and biological materials for industrial, scientific and agricultural use
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Biological materials, namely, genetically modified cells,
genetic material and vectors including cosmids, plasmids,
viral material, or chromosomes for production of human,
animal and synthetic proteins for scientific and
pharmaceutical research; human or animal blood, tissue,
blood cells and stem cell products for use in scientific
and pharmaceutical research; bioconjugates for drug
development research; bioscience products including primary
cells, cell cultures and transfection products for
life-science research; nutritional chemical ingredients in
bulk powder, tablet, capsule, gel, powder, and liquid form
used in the manufacture of dietary and nutritional
supplements or food additives; biological preparations,
namely, genetically modified cells, genetic material and
vectors, including cosmids, plasmids, viral material, or
chromosomes for the production of human, animal and
synthetic proteins for commercial use; blood, tissue, blood
cells and products based on human or animal stem cells, for
commercial use; bioconjugates for drug development; life
science products including primary cells, cell cultures and
transfection products for commercial use in human and animal
therapies; biopharmaceutical products, including antibodies
and proteins for scientific and pharmaceutical research. Biological materials for medical and pharmaceutical use,
namely, genetically modified cells, genetic material and
vectors including cosmids, plasmids, viral material, or
chromosomes for production of human, animal and synthetic
proteins for medical, clinical and commercial use; human or
animal blood, tissue, blood cells and stem-cell products for
medical, clinical and commercial use; biopharmaceuticals
including antibodies and proteins for medical and
pharmaceutical use; bioscience products including primary
cells, cell cultures and transfection products for medical,
clinical and commercial use in human and animal therapies;
dietary and nutritional supplements; nutritional ingredients
sold as components of dietary regimes and nutritional
supplements for medical use in bulk, in the form of tablets,
capsules, gel, powder, and liquid or as food additives.
14.
CARBON-SOURCE REGULATED PROTEIN PRODUCTION IN A RECOMBINANT HOST CELL
A recombinant host cell comprising an endogenous gene encoding a FLO8 protein comprising the amino acid sequence identified as SEQ ID NO:1 or a homologue thereof, which host cell is engineered by one or more genetic modifications to reduce expression of said gene compared to the host cell prior to said one or more genetic modifications, and which host cell comprises a heterologous expression cassette comprising a gene of interest (GOI) under the control of an expression cassette promoter (ECP) which ECP is repressible by a non-methanol carbon source, and a method of producing a protein of interest using said recombinant host cell.
Applicant: Lonza Ltd Title: Method for operating a heat exchanger unit for changing the physical state of matter of an aqueous formulation Our ref.: LZA27238PCT Date: June 29, 2023 Page 43 of 43 Abstract Method for operating a heat exchanger unit for freezing or thawing an aqueous formulation comprising the steps of: segmenting a target temperature course into two distinct phases, wherein at least one phase refers to a change in physical state of an aqueous formulation; determining a control parameter variation, based on which operation of the heat exchanger unit is to be controlled 5 during an operating cycle; performing a test run operating cycle by operating the heat exchange unit based on the determined control parameter variation and by measuring an aqueous formulation temperature course; segmenting the measured temperature course into two distinct phases, wherein at least one phase refers to a change in physical state of matter; adapting the determined control parameter variation based on a comparison of the segmented measured substance 10 temperature course with the segmented target temperature course; and operating the heat exchanger unit based on the adapted control parameter variation. (Figure 2)
01 - Chemical and biological materials for industrial, scientific and agricultural use
05 - Pharmaceutical, veterinary and sanitary products
40 - Treatment of materials; recycling, air and water treatment,
42 - Scientific, technological and industrial services, research and design
Goods & Services
Biological preparations, other than for medical or
veterinary use, namely genetically modified cells and
vectors for production of human, animal and synthetic
proteins, for clinical and commercial purposes in scientific
research and for use in pharmaceutical research. Biological preparations for medical use, namely genetically
modified cells and genetically modified vectors for
production of human, animal and synthetic proteins for
medical, clinical and commercial use in human and animal
therapies. Custom manufacturing according to third-party orders and
specifications of genetically modified cells and vectors for
production of human, animal and synthetic proteins, for
clinical and commercial use in scientific research and in
pharmaceutical research, as well as for clinical and
commercial use in human and animal therapies. Scientific and medical research in the field of
biotechnology; Technical consultancy and project planning in
the field of biological research relating to proteins;
research and development in the field of protein research
for others.
Provided are viral vector formulations comprising a globular protein such as an albumin Also provided are viral vector formulations comprising a polysaccharide such as an hyaluronic acid. The provided viral vector formulations have increased stability and reduced viral vector aggregation.
A recombinant eukaryotic host cell expressing a gene of interest (GOI) which is engineered by genetic modifications to increase expression of two or more genes encoding translation initiation factors (TIF genes) of the messenger ribonucleoprotein (mRNP), compared to the host cell prior to said one or more genetic modifications, wherein said TIF genes comprise at least a gene encoding eIF4A and a gene encoding eIF4G, and wherein expression of at least one of said TIF genes is under transcriptional control of a promoter different from the promoter controlling expression of said GOI.
C07K 14/47 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from animalsPeptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from humans from vertebrates from mammals
C12N 15/79 - Vectors or expression systems specially adapted for eukaryotic hosts
01 - Chemical and biological materials for industrial, scientific and agricultural use
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Biological materials, namely, genetically modified cells for scientific and research use; biological tissue in the nature of genetic material and vectors, namely, cosmids, plasmids, viral material, or chromosomes for production of human, animal and synthetic proteins for scientific and pharmaceutical research; biological tissue, namely, human or animal blood, tissue and stem cells for use in scientific and pharmaceutical research; bioconjugates for scientific and pharmaceutical research; bioscience products, being biological tissue in the nature of primary cells, cell cultures and transfection compounds for life-science research; nutritional chemical compounds in bulk powder, tablet, capsule, gel, powder, and liquid form used in the manufacture of dietary and nutritional supplements or food additives; biological preparations, namely, genetically modified cells, genetic material and vectors in the nature of cosmids, plasmids, viral material, or chromosomes for the production of human, animal and synthetic proteins for commercial use, other than for medical or veterinary use; biological preparations for use in industry and science, namely, blood, tissue, blood cells and human or animal stem cells, for commercial use; biological preparations for use in industry and science, namely, bioconjugates for drug development; biological preparations for use in industry and science, namely, primary cells, cell cultures and transfection animal tissue for commercial use in human and animal therapies; biopharmaceutical chemicals, namely, monoclonal antibodies and proteins for scientific and pharmaceutical research Biological materials for medical and pharmaceutical use, namely, genetically modified cells, genetic material and vectors, namely,
cosmids, plasmids, viral material, or chromosomes for production of human, animal and synthetic proteins for medical, clinical and
commercial use; human or animal blood, tissue, blood cells and stem-cells for medical, clinical and commercial use;
biopharmaceuticals, namely, antibodies and proteins for medical and pharmaceutical use; bioscience products, namely, primary
cells, cell cultures and transfection products in the nature of human and animal cells for medical, clinical and commercial use in
human and animal therapies; dietary and nutritional supplements; nutritional ingredients in the nature of nutritional supplements
as components of dietary regimes and nutritional supplements for medical use in bulk, in the form of tablets, capsules, gel,
powder, and liquid or as food additives
01 - Chemical and biological materials for industrial, scientific and agricultural use
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
(1) Préparations biologiques, nommément cellules, matériel génétique et vecteurs génétiquement modifiés, y compris cosmides, plasmides, matériel viral ou chromosomes pour la production de protéines humaines, animales et synthétiques pour la recherche scientifique et pharmaceutique; sang, tissus, cellules sanguines et produits à base de cellules souches humains ou animaux pour la recherche scientifique et pharmaceutique; bioconjugués pour la recherche sur le développement de médicaments; produits des sciences de la vie, y compris cellules primaires, cultures cellulaires et produits de transfection pour la recherche en sciences de la vie; ingrédients nutritionnels chimiques en vrac, comprimés, capsules, gel, poudre et liquide, destinés à la fabrication de suppléments diététiques et nutritionnels ou d'additifs alimentaires; préparations biologiques, nommément cellules, matériel génétique et vecteurs génétiquement modifiés, y compris cosmides, plasmides, matériel viral ou chromosomes pour la production de protéines humaines, animales et synthétiques à usage commercial; sang, tissus, cellules sanguines et produits à base de cellules souches humains ou animaux à usage commercial; bioconjugués pour le développement de médicaments; produits des sciences de la vie, y compris cellules primaires, cultures cellulaires et produits de transfection à des fins commerciales en thérapie humaine et animale; produits biopharmaceutiques, y compris anticorps et protéines pour la recherche scientifique et pharmaceutique.
(2) Préparations biologiques à usage médical et pharmaceutique, nommément cellules génétiquement modifiées, préparations et vecteurs génétiques, y compris cosmides, plasmides, matériel viral ou chromosomes pour la production de protéines humaines, animales et synthétiques à usage médical et clinique; sang, tissus, cellules sanguines et produits à base de cellules souches humains ou animaux à usage médical et clinique; produits biopharmaceutiques, y compris anticorps et protéines à usage médical et pharmaceutique; produits des sciences de la vie, y compris cellules primaires, cultures cellulaires et produits de transfection à des fins médicales et cliniques en thérapie humaine et animale; suppléments diététiques et nutritionnels; ingrédients nutritifs vendus comme composants de régimes alimentaires et de suppléments nutritionnels à usage médical en vrac, sous forme de comprimés, de capsules, de gel, de poudre et de liquide ou comme additifs alimentaires.
A method of reducing precipitation in a bacterial fermentation process for producing a fermentation product, which fermentation process comprises the steps:
a) cultivating the host cells for bacterial growth in a batch phase using a batch medium; and
b) cultivating the host cells for producing the fermentation product in a fed-batch phase using a feed medium;
which feed and batch media are each unprecipitated media solutions, wherein:
i) the batch medium comprises an amount of calcium salts, magnesium salts, phosphate salts and at least one chelating agent, which is a citrate salt and/or citric acid at an amount of at least 5 mM, and/or EDTA at an amount of at least 1 mM; and
ii) the feed medium comprises an amount of calcium salts which is at least 1 mM, and which is at least 5-fold higher as compared to the batch medium (M/M); and
iii) the feed medium comprises an amount of magnesium salts which is at least 3 mM, and which is at least 2-fold higher as compared to the batch medium (M/M); and
iv) the feed medium comprises an amount of phosphate salts which is less than 90% of the amount comprised in the batch medium (M/M).
01 - Chemical and biological materials for industrial, scientific and agricultural use
05 - Pharmaceutical, veterinary and sanitary products
40 - Treatment of materials; recycling, air and water treatment,
42 - Scientific, technological and industrial services, research and design
Goods & Services
(1) Préparations biologiques, non à usage médical ou vétérinaire, à savoir cellules et vecteurs génétiquement modifiés pour la production de protéines humaines, animales et synthétiques, à des fins cliniques et commerciales pour la recherche scientifique et pour l'utilisation dans la recherche pharmaceutique.
(2) Préparations biologiques à usage médical, à savoir cellules génétiquement modifiées et vecteurs génétiquement modifiés pour la production de protéines humaines, animales et synthétiques à usage médical, clinique et commercial en thérapie humaine et animale. (1) Fabrication sur mesure selon les commandes et spécifications de tiers de cellules et de vecteurs génétiquement modifiés pour la production de protéines humaines, animales et synthétiques, pour une utilisation clinique et commerciale dans la recherche scientifique et la recherche pharmaceutique, et pour une utilisation clinique et commerciale en thérapie humaine et animale.
(2) Recherche scientifique et médicale dans le domaine de la biotechnologie; conseils techniques et planification de projets dans le domaine de la recherche sur les protéines biologiques; recherche et développement pour des tiers dans le domaine de la recherche sur les protéines.
01 - Chemical and biological materials for industrial, scientific and agricultural use
05 - Pharmaceutical, veterinary and sanitary products
40 - Treatment of materials; recycling, air and water treatment,
42 - Scientific, technological and industrial services, research and design
Goods & Services
Biological preparations, namely, genetically modified cells
and vectors for the production of human, animal, and
synthetic proteins, for use in scientific research,
pharmaceutical research and for clinical and industrial use. Biological products, namely, genetically modified cells and
vectors for the production of human, animal, and synthetic
proteins for clinical and industrial use in human and animal
therapeutics. Custom manufacturing, to order and according to third-party
specifications, of genetically modified cells and vectors
for production of human, animal and synthetic proteins, for
use in scientific research, in pharmaceutical research and
for clinical and commercial use, as well as for clinical and
commercial use in human and animal therapies. Medical and scientific research and technical consultation
and design in the field of protein expression; Research and
development in the field of protein expression; research,
development, and industrial production in the field of
protein expression for third parties.
01 - Chemical and biological materials for industrial, scientific and agricultural use
05 - Pharmaceutical, veterinary and sanitary products
40 - Treatment of materials; recycling, air and water treatment,
42 - Scientific, technological and industrial services, research and design
Goods & Services
Biological preparations, namely, genetically modified cells
and vectors for the production of human, animal, and
synthetic proteins, for use in scientific research,
pharmaceutical research and for clinical and industrial use. Biological products, namely, genetically modified cells and
vectors for the production of human, animal, and synthetic
proteins for clinical and industrial use in human and animal
therapeutics. Custom manufacturing, to order and according to third-party
specifications, of genetically modified cells and vectors
for production of human, animal and synthetic proteins, for
use in scientific research, in pharmaceutical research and
for clinical and commercial use, as well as for clinical and
commercial use in human and animal therapies. Medical and scientific research and technical consultation
and design in the field of protein expression; Research,
development, and industrial production in the field of
protein expression; research, development, and industrial
production in the field of protein expression for third
parties.
01 - Chemical and biological materials for industrial, scientific and agricultural use
05 - Pharmaceutical, veterinary and sanitary products
40 - Treatment of materials; recycling, air and water treatment,
42 - Scientific, technological and industrial services, research and design
Goods & Services
Biological preparations for scientific research, pharmaceutical research, clinical research and for industrial purposes namely, genetically modified cells and vectors for production of human, animal and synthetic proteins Biological preparations, namely, genetically modified cells and genetically modified vectors for production of human, animal and synthetic proteins, for medical and clinical use in human and animal therapies Custom manufacturing according to third-party orders and specifications of genetically modified cells and vectors for production of human, animal and synthetic proteins, for clinical and commercial use in scientific research and in pharmaceutical research, as well as for clinical and commercial use in human and animal therapies Medical and scientific research in the field of biotechnology; technical consultancy and project planning in the field of biological research relating to proteins; scientific research and development in the field of protein research for others
26.
Process and system for propagating cell cultures while preventing lactate accumulation
A predictive model is described that can predict parameter concentrations in the future based on initial, measured concentrations and historical data. A plurality of multivariate techniques can be used to construct the predictive model capable of forecasting concentrations over multiple and diverse cell lines. The predictive model is also scalable. In one embodiment, a future lactate concentration trajectory is determined and at least one condition within a bioreactor is changed or modified to maintain lactate concentration within desired ranges.
The present invention is in the field of recombinant biotechnology, in particular in the field of protein expression. The invention generally relates to a method of expressing a protein of interest (POI) from a host cell. The invention relates particularly to improving a host cell's capacity to express and/or secrete a protein of interest and use of the host cell for protein expression. The invention also relates to cell culture technology, and more specifically to culturing cells to produce desired molecules for medical purposes or food products.
The present invention relates to a method and an apparatus for simulating and analyzing the behavior of a substance in an eye, in particular in the vitreous humor. Further, the present invention refers to a method of providing a vitreous humor, and to a buffer fluid for use in such a method and apparatus.
The present invention relates to a method for reducing polysorbate degradation by low amounts of citric acid in a protein formulation and a protein formulation with low amounts of citric acid having reduced polysorbate degradation.
The monitoring and control of bioprocesses is provided. The present disclosure provides the ability to generate generic calibration models, independent of cell line, using inline Raman probes to monitor changes in glucose, lactate, glutamate, ammonium, viable cell concentration (VCC), total cell concentration (TCC) and product concentration. Calibration models were developed from cell culture using two different CHOK1SV GS-KO™ cell lines producing different monoclonal antibodies (mAbs). Developed predictive models, qualified using an independent CHOK1SV GS-KO™ cell line not used in calibration, measured changes in glucose, lactate, ammonium, VCC, and TCC with minor prediction errors over the course of cell culture with minimal cell line dependence. The development of these generic models allows the application of spectroscopic PAT techniques in a clinical manufacturing environment, where processes are typically run once or twice in GMP manufacturing based on a common platform process.
A variable diameter bioreactor vessel is provided that includes a first vessel section having a first diameter configured to hold a liquid media and biologic material, and a second vessel section having a second diameter that is greater than the first diameter such that the liquid media can be increased from a first volume to a second volume within the vessel.
Described herein are compositions and methods for identifying, selecting, or culturing cells comprising a subject nucleic acid sequence of interest. Generally, a nucleic acid comprising a subject nucleic acid and a sequence encoding an enzyme molecule involved in biosynthesis of an amino acid is introduced into a cell. The cell is then grown on media lacking the amino acid, such that cells comprising the introduced nucleic acid are capable of growth. In some instances, the cell further comprises an inhibitor of the enzyme molecule to increase the stringency of the selection.
01 - Chemical and biological materials for industrial, scientific and agricultural use
05 - Pharmaceutical, veterinary and sanitary products
40 - Treatment of materials; recycling, air and water treatment,
42 - Scientific, technological and industrial services, research and design
Goods & Services
(1) Préparations biologiques, nommément cellules et vecteurs génétiquement modifiés pour la production de protéines humaines, animales et synthétiques pour la recherche scientifique, la recherche pharmaceutique, à des fins cliniques et industrielles.
(2) Produits biologiques, nommément cellules et vecteurs génétiquement modifiés pour la production de protéines humaines, animales et synthétiques à usage clinique et industriel en thérapie humaine et animale. (1) Fabrication sur mesure, sur commande et selon les spécifications de tiers, de cellules et de vecteurs génétiquement modifiés pour la production de protéines humaines, animales et synthétiques destinées à la recherche scientifique, à la recherche pharmaceutique et à des utilisations cliniques et commerciales et à des fins cliniques et commerciales dans thérapeutique humaine et animale.
(2) Recherche médicale et scientifique ainsi que consultation et conception techniques dans le domaine de l'expression de protéines; recherche et développement dans le domaine de l'expression de protéines; recherche, développement et production industrielle pour des tiers dans le domaine de l'expression des protéines.
01 - Chemical and biological materials for industrial, scientific and agricultural use
05 - Pharmaceutical, veterinary and sanitary products
40 - Treatment of materials; recycling, air and water treatment,
42 - Scientific, technological and industrial services, research and design
Goods & Services
(1) Préparations biologiques, nommément cellules et vecteurs génétiquement modifiés pour la production de protéines humaines, animales et synthétiques pour la recherche scientifique, la recherche pharmaceutique, à des fins cliniques et industrielles.
(2) Produits biologiques, nommément cellules et vecteurs génétiquement modifiés pour la production de protéines humaines, animales et synthétiques à usage clinique et industriel en thérapie humaine et animale. (1) Fabrication sur mesure, sur commande et selon les spécifications de tiers, de cellules et de vecteurs génétiquement modifiés pour la production de protéines humaines, animales et synthétiques destinées à la recherche scientifique, à la recherche pharmaceutique et à des utilisations cliniques et commerciales et à des fins cliniques et commerciales dans thérapeutique humaine et animale.
(2) Recherche médicale et scientifique ainsi que consultation et conception techniques dans le domaine de l'expression de protéines; recherche, développement et production industrielle dans le domaine de l'expression de protéines; recherche, développement et production industrielle pour des tiers dans le domaine de l'expression des protéines.
01 - Chemical and biological materials for industrial, scientific and agricultural use
05 - Pharmaceutical, veterinary and sanitary products
40 - Treatment of materials; recycling, air and water treatment,
42 - Scientific, technological and industrial services, research and design
Goods & Services
Biological preparations for scientific research, pharmaceutical research, clinical research and for industrial purposes namely, genetically modified cells and vectors for production of human, animal and synthetic proteins Biological preparations for medical use, namely, genetically modified cells and genetically modified vectors for production of human, animal and synthetic proteins for medical, and clinical use in human and animal therapies Custom manufacturing according to third-party orders and specifications of genetically modified cells and vectors for production of human, animal and synthetic proteins, for clinical and commercial use in scientific research and in pharmaceutical research, as well as for clinical and commercial use in human and animal therapies Medical and scientific research in the field of protein expression; technical consultation and design in the field of protein expression research; scientific research and development in the field of protein expression; scientific research and development in the field of protein expression for third parties
01 - Chemical and biological materials for industrial, scientific and agricultural use
05 - Pharmaceutical, veterinary and sanitary products
40 - Treatment of materials; recycling, air and water treatment,
42 - Scientific, technological and industrial services, research and design
Goods & Services
Biological preparations for scientific research, pharmaceutical research, clinical research and for industrial purposes namely, genetically modified cells and vectors for production of human, animal and synthetic proteins Biological preparations for medical use, namely, genetically modified cells and genetically modified vectors for production of human, animal and synthetic proteins for medical, and clinical use in human and animal therapies Custom manufacturing according to third-party orders and specifications of genetically modified cells and vectors for production of human, animal and synthetic proteins, for clinical and commercial use in scientific research and in pharmaceutical research, as well as for clinical and commercial use in human and animal therapies Medical and scientific research in the field of protein expression; technical consultation and design in the field of protein expression research; scientific research and development in the field of protein expression; scientific research and development in the field of protein expression for third parties
39.
Device and method for leakage testing of a connection between a rubber stopper and a corresponding drug container
The invention concerns the field of container closure integrity (CCI) and the testing of CCI and relates to a device and a method for providing a displacement of a rubber stopper for leakage testing of a connection between the rubber stopper and a corresponding drug container which can be used for storing drugs under sterile conditions and which is closed by said rubber stopper.
G01M 3/22 - Investigating fluid tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point using special tracer materials, e.g. dye, fluorescent material, radioactive material for pipes, cables, or tubesInvestigating fluid tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point using special tracer materials, e.g. dye, fluorescent material, radioactive material for pipe joints or sealsInvestigating fluid tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point using special tracer materials, e.g. dye, fluorescent material, radioactive material for valves
G01M 3/28 - Investigating fluid tightness of structures by using fluid or vacuum by measuring rate of loss or gain of fluid, e.g. by pressure-responsive devices, by flow detectors for pipes, cables, or tubesInvestigating fluid tightness of structures by using fluid or vacuum by measuring rate of loss or gain of fluid, e.g. by pressure-responsive devices, by flow detectors for pipe joints or sealsInvestigating fluid tightness of structures by using fluid or vacuum by measuring rate of loss or gain of fluid, e.g. by pressure-responsive devices, by flow detectors for valves
01 - Chemical and biological materials for industrial, scientific and agricultural use
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Cells for scientific use, laboratory use, medical research
and clinical use, including genetic material for the
production of recombinant proteins. Biological products, namely, genetically modified cells and
genetically modified vectors for the production of
recombinant proteins for medical use and for clinical and
commercial use in human and animal therapies; gene therapy
products, namely, modified cells and modified cell
platforms.
A method for producing of a protein of interest (POI) in a yeast host cell that is modified to comprise within one or more expression cassettes heterologous nucleic acid molecules encoding helper factors and a gene of interest (GOI) encoding the POI, wherein: a) a first helper factor comprises at least 90% sequence identity to SEQ ID NO:1; b) a second helper factor comprises at east 90% sequence identity to SEQ ID NO:3; and c) a third helper factor comprises at least 90% sequence identity to SEQ ID NO:5; which method comprises (i) culturing said host cell in a culture medium under conditions to co-express said heterologous nucleic acid molecules and to secrete said POI into the host cell culture; and (ii) recovering the POI from the host cell culture.
The present disclosure provides methods for preparing digested virus proteins, including adenovirus and adeno-associated virus capsid proteins, from a sample of virus proteins, as well as methods of analyzing such digested virus proteins via liquid chromatography-tandem mass spectrometry. The methods include the use of a mixture of sodium deoxycholate (SDC) and N-dodecyl-beta-D-Maltoside (DDM) to rapidly and easily prepare the digested virus proteins.
The present disclosure features methods and compositions for modulating lipid metabolism to achieve improved production and quality of recombinant products, such as next generation biologics. Modulation of lipid metabolism as described herein includes, for example, introducing a lipid metabolism modulator described herein to a cell or a cell-free system. Also encompassed by the present disclosure are engineered cells with improved production capacity and improved product quality, methods for engineering such cells, and preparations and mixtures comprising the products from such cells.
C12P 21/02 - Preparation of peptides or proteins having a known sequence of two or more amino acids, e.g. glutathione
C07K 14/47 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from animalsPeptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from humans from vertebrates from mammals
C07K 16/00 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies
C12N 5/071 - Vertebrate cells or tissues, e.g. human cells or tissues
A single-use bioreactor is provided. The single-use bioreactor may include a bioprocess container, a shell, at least one agitator, at least one sparger, at least one gas filter inlet port for the sparger(s) and headspace overlay, at least one fill port, at least one harvest port, at least one sample port, and at least one probe. In examples, at least one controller may monitor and control one or more parameters associated with the single-use bioreactor A method to cultivate and propagate mammalian cells is also provided. The method may include cultivating under suitable conditions and in a suitable culture medium in a first single-use bioreactor, transferring the medium containing the cells obtained by propagation from the at least one mammalian cell is into a second single-use bioreactor, transferring the medium containing the cells obtained by propagation from the at least one mammalian cell is into a third single-use bioreactor, and cultivating the cells in the third bioreactor.
C12M 1/00 - Apparatus for enzymology or microbiology
C12M 1/06 - Apparatus for enzymology or microbiology with gas introduction means with agitator, e.g. impeller
B01F 23/231 - Mixing gases with liquids by introducing gases into liquid media, e.g. for producing aerated liquids by bubbling
B01F 27/053 - Stirrers characterised by their elements, materials or mechanical properties characterised by their materials
B01F 27/86 - Mixers with rotary stirring devices in fixed receptaclesKneaders with stirrers rotating about a substantially vertical axis co-operating with deflectors or baffles fixed to the receptacle
B01F 27/191 - Stirrers with two or more mixing elements mounted in sequence on the same axis with similar elements
B01F 27/113 - Propeller-shaped stirrers for producing an axial flow, e.g. shaped like a ship or aircraft propeller
B01F 35/513 - Flexible receptacles, e.g. bags supported by rigid containers
The present disclosure provides a method of purifying polysaccharides from a cell lysate, comprising partially purifying the cell lysate comprising an impurity and a polysaccharide to obtain a clarified cmde lysate; mixing the clarified crude lysate with a neutralization solution comprising a salt to form a neutralized lysate; mixing the neutralized lysate with a precipitation solution comprising cetyltrimethylammonium bromide to form a first supernatant and a first precipitate; and separating the first precipitate from the first supernatant, wherein the polysaccharide is located in the first supernatant. The present disclosure further provides a method of making a polysaccharide vaccine. Also provided are vaccines, delivery systems, compositions and polysaccharides made by the methods described herein.
Provided are compositions comprising a population of cells that are amenable to freezing or lyophilization while maintaining viable cells. The compositions comprise a monosaccharide, urea and, in some embodiments, a bulking agent. Also provided are methods for preparing and storing cells via freezing or lyophilization in a manner that allows cells to remain viable during storage.
A process and system for producing an inoculum for downstream cell production is disclosed. The inoculum is produced in a perfusion bioreactor in which the nutrient media feed is increased as the biomass concentration increases within the bioreactor. A biomass sensor can be used to periodically or continuously monitor biomass concentration. This information can be fed to a controller for automatically increasing nutrient media feed rates in a manner that is directly proportional to producing an inoculum with an increase cell density. The process and system can also include an automated subsystem for maintaining constant volume levels within the perfusion bioreactor during the process.
Described herein are production cells, and methods for identifying, selecting, or culturing production cells comprising tyrosine auxotrophy selection marker system, based on a combination of sequence encoding a phenylalanine hydroxylase (PAH) which lacks a functional N-terminal regulatory domain, and a sequence encoding a GTP cyclohydrolase 1 (GCH1). Also described are methods of making a production cell and making a product with said production cell.
A method for preparing an amorphous solid dispersion by spray drying a spray solution comprising a) a mixed solvent, the mixed solvent comprising i. a solvent 1 selected from the group consisting of methyl acetate, methyl formate, ethyl acetate, ethyl formate and mixtures thereof; ii. a solvent 2 selected from the group consisting of methanol, ethanol and mixtures thereof; with the ratio (w:w) of solvent 1 to solvent 2 being from 10:90 to 90:10; b) an active agent; c) a dispersion polymer, wherein: c1) said dispersion polymer is HPMC; or c2) said dispersion polymer is PVP, provided that said mixed solvent does not consist of a mixture of methanol and ethyl acetate; or c3) said dispersion polymer is selected from the group consisting of: hydroxypropyl methylcellulose acetate succinate (HPMCAS), hydroxypropyl methylcellulose phthalate (HPMCP), hydroxypropyl cellulose (HPC), cellulose acetate phthalate (CAP), carboxymethyl ethyl cellulose (CMEC), poly(vinylpyrrolidone-co-vinyl acetate) (PVPVA), polymethacrylates such as poly(methacrylic acid-co-methyl methacrylate) (PMMAMA) or poly(methacrylic acid-co-ethyl acrylate), [acetic acid ethenyl ester, polymer with 1-ethenylhexahydro-2H- azepin-2-one and. alpha. -hydro-. omega. -hydroxypoly(oxy-I,2- ethanediyl), graft], or a combination thereof.
A61K 31/635 - Compounds containing para-N-benzene- sulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonohydrazide having a heterocyclic ring, e.g. sulfadiazine
A61K 31/506 - PyrimidinesHydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
A61K 31/5377 - 1,4-Oxazines, e.g. morpholine not condensed and containing further heterocyclic rings, e.g. timolol
50.
SPRAY DRYING OF API IN SUPERSATURATED SOLUTIONS WITH FORMIC ACID
The invention discloses a method for preparation of spray dried solid dispersions (SDD)comprising an active pharmaceutical ingredient (API) and a dispersion polymer (DISPPOL), wherein the spray drying is done with a supersaturated solution of API in a solvent mixture comprising two solvents, this supersaturated solution further comprising DISPPOL.
01 - Chemical and biological materials for industrial, scientific and agricultural use
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
(1) Cellules à usage scientifique, à usage de laboratoire, pour la recherche médicale et à usage clinique, y compris le matériel génétique pour la production de protéines recombinantes.
(2) Produits biologiques, nommément cellules génétiquement modifiées et vecteurs génétiquement modifiés pour la production de protéines recombinantes à usage médical et à usage clinique et commercial dans le cadre de thérapies humaines et animales; produits de thérapie génique, nommément cellules modifiées et plateformes cellulaires modifiées.
09 - Scientific and electric apparatus and instruments
35 - Advertising and business services
42 - Scientific, technological and industrial services, research and design
Goods & Services
Data and file management and database software; software for searching and retrieving information across a computer network; platform software; downloadable graphic design templates; computer software to enable searching and retrieval of data; drawing software; table representation software; software for creating customized bills of materials. Data management; data processing management; data collection services; systematization of data in computer databases; compilation and systematization of information in databanks; compilation of data relating to bills of materials. Software development; development of computer platforms; development and creation of software for creating customized bills of materials.
The present disclosure provides a method of producing a population of lyophilized cells, comprising: (a) freezing a composition comprising a population of cells, an aqueous component, a polyol, a sugar, and a polysaccharide; and (b) removing at least 90% of the aqueous component from the frozen composition to produce the population of lyophilized cells. On some embodiments, the disclosure provides a method of producing a population of reconstituted viable cells, comprising: (a) freezing a composition comprising a population of cells, an aqueous component, a polyol, a sugar, and a polysaccharide; (b) removing at least 90% of the aqueous component from the frozen composition to produce the population of lyophilized cells, and (c) resuspending the population of lyophilized cells in a reconstitution agent to form a reconstituted composition, wherein at least 1% of the cells are viable.
A campus for fabricating at least one pharmaceutical product has one or more customizable facilities each configured to manufacture the at least one pharmaceutical product, a media/buffer plant, and a utility building connected by a utility line to the media/buffer plant and/or the one or more customizable facilities to provide at least one first utility to the media/buffer plant and/or the one or more customizable facilities via the utility line.
Provided are methods for derivatizing a peroxo compound in a sample by combining the sample with a dihalomethane to form a mixture. Also provided are methods for detecting a peroxo compound in a sample by combining the sample with a dihalomethane to form a mixture, where the peroxo compound oxidizes the dihalomethane to form a detectable tetrahaloethane, indicating the presence of the tetrahaloethane indicates the presence of the peroxo compound.
G01N 31/22 - Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroupsApparatus specially adapted for such methods using chemical indicators
G01N 21/78 - Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator producing a change of colour
G01N 30/88 - Integrated analysis systems specially adapted therefor, not covered by a single one of groups
G01N 33/00 - Investigating or analysing materials by specific methods not covered by groups
The present disclosure provides an ultraviolet light filter for use in photostability testing chambers, and in particular, filters that are designed to allow for air ventilation and maintenance of desired temperatures at the sample level during light exposure testing.
A method for producing a purified polyclonal anti-HCP antibody preparation is disclosed. The method can comprise acquiring a sample comprising antibodies from an animal immunized with HCP of a host cell, separating antibodies from the sample by contacting the sample with a protein A affinity reagent to provide an antibody preparation, separating anti-HCP antibody from the antibody preparation by contacting the antibody preparation with an HCP-affinity reagent comprising HCP coupled to a substrate, and isolating the separated polyclonal anti-HCP antibody preparation.
Disclosed herein are, inter alia, methods and compositions useful for detecting and/or quantifying host cell proteins during the production of a product, e.g., a recombinant protein, e.g., an antibody.
The present invention relates to a nucleic acid molecule encoding a fusion protein comprising a secretion signal comprising (i) a signal peptide sequence originating from a KRE1 protein or a signal peptide sequence originating from a SWP1 protein; and optionally (ii) an ?-mating factor (MF?) pro-sequence, and a protein of interest. The present invention further relates to a secretion signal as defined herein, an expression cassette comprising said nucleic acid molecule as well as recombinant eukaryotic host cells comprising said nucleic acid molecule or expression cassette. Further encompassed is a method of manufacturing a protein of interest in a eukaryotic host cell and a method of increasing the secretion of a protein of interest from a eukaryotic host cell. Further provided is the use of the secretion signal for increasing the secretion of a recombinant protein of interest from a eukaryotic host cell and the use of the recombinant host cell for manufacturing a recombinant protein of interest.
The present invention relates to a nucleic acid molecule encoding a fusion protein comprising a secretion signal comprising (i) a signal peptide sequence originating from a KRE1 protein or a signal peptide sequence originating from a SWP1 protein; and optionally (ii) an α-mating factor (MFα) pro-sequence, and a protein of interest. The present invention further relates to a secretion signal as defined herein, an expression cassette comprising said nucleic acid molecule as well as recombinant eukaryotic host cells comprising said nucleic acid molecule or expression cassette. Further encompassed is a method of manufacturing a protein of interest in a eukaryotic host cell and a method of increasing the secretion of a protein of interest from a eukaryotic host cell. Further provided is the use of the secretion signal for increasing the secretion of a recombinant protein of interest from a eukaryotic host cell and the use of the recombinant host cell for manufacturing a recombinant protein of interest.
A method of producing a protein of interest (POI) by culturing a recombinant eukaryotic cell line comprising an expression construct comprising a regulatable promoter and a nucleic acid molecule encoding a POI under the transcriptional control of said promoter, comprising the steps a) cultivating the cell line with a basal carbon source repressing the promoter, b) cultivating the cell line with a limited amount of a supplemental carbon source de-repressing the promoter to induce production of the POI at a transcription rate of at least 15% as compared to the native pGAP promoter, and c) producing and recovering the POI; and further an isolated regulatable promoter and a respective expression system.
The present disclosure provides methods for derivatizing and detecting aldehydes and ketones formed as degradation products of fatty acids and fatty acid esters. The methods form stable derivatives of the aldehydes and ketones that allow for subsequent separation and detection.
G01N 31/22 - Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroupsApparatus specially adapted for such methods using chemical indicators
C07C 29/16 - Preparation of compounds having hydroxy or O-metal groups bound to a carbon atom not belonging to a six-membered aromatic ring by oxo-reaction combined with reduction
64.
Purification Process for Biological Molecules Such as Plasmid DNA Using Anionic Exchange Chromatography
The present invention provides new, improved methods for the purification or isolation of a biological molecule of interest, such as plasmid DNA (pDNA) involving an anion exchange (AEX) chromatography step. The method achieves the simple and effective removal of impurities such as RNA, genomic DNA, proteins, cellular fractions, or combinations thereof. The novel methods of the present invention are particularly suitable for large-scale production plants and provide for purified biomolecules (such as pDNA) with excellent quality and good yields, while also allowing for faster processing times and reduced costs.
The present disclosure is directed to in vitro methods for determining local tolerance. In some embodiments, the in vitro method is a miscibility test.
01 - Chemical and biological materials for industrial, scientific and agricultural use
05 - Pharmaceutical, veterinary and sanitary products
09 - Scientific and electric apparatus and instruments
42 - Scientific, technological and industrial services, research and design
45 - Legal and security services; personal services for individuals.
Goods & Services
Biochemicals, namely, monoclonal or trimeric antibodies and
derivatives thereof, for in-vivo or in-vitro scientific
research and development to treat cancers, inflammatory
diseases, autoimmune diseases, infectious diseases and
cardiovascular diseases and for use in laboratories,
diagnostics and analytics for scientific or research use. Pharmaceutical preparations based on human monoclonal or
trimeric antibodies and derivatives thereof, to treat
cancers, inflammatory diseases, autoimmune diseases,
infectious diseases and cardiovascular diseases, and for
related diagnostic or therapeutic use, and for use in
related assays. Computer software for scientific laboratory research and
commercial use for applications with monoclonal or trimeric
antibodies used to treat cancers, inflammatory diseases,
autoimmune diseases, infectious diseases and cardiovascular
diseases. Medical and scientific research, protein engineering,
pharmaceutical product development, industrial research and
contract research services, all related to human monoclonal
or trimeric antibodies to treat cancers, inflammatory
diseases, autoimmune diseases, infectious diseases and
cardiovascular diseases; Computer programming for
acquisition and processing of medical data in the context of
medical-scientific research, development and therapy with
monoclonal or trimeric antibodies and their derivatives. Legal services related to patent exploitation, namely patent
licensing; licensing of intellectual property in the field
of monoclonal or trimeric antibodies for laboratories,
diagnostics and analytics for scientific or research use.
A recombinant eukaryotic host cell expressing a gene of interest (GOI) which is engineered by genetic modifications to increase expression of two or more genes encoding translation initiation factors (TIF genes) of the messenger ribonucleoprotein (mRNP), compared to the host cell prior to said one or more genetic modifications, wherein said TIF genes comprise at least a gene encoding eIF4A and a gene encoding eIF4G, and wherein expression of at least one of said TIF genes is under transcriptional control of a promoter different from the promoter controlling expression of said GOI..
C07K 14/47 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from animalsPeptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from humans from vertebrates from mammals
C12N 15/67 - General methods for enhancing the expression
C12N 15/79 - Vectors or expression systems specially adapted for eukaryotic hosts
C12N 15/81 - Vectors or expression systems specially adapted for eukaryotic hosts for fungi for yeasts
A customizable facility for manufacturing at least one product has at least one modular unit in communication with at least one central unit configured to provide utilities to the at least one modular unit. In some embodiments, the central unit(s) and modular unit(s) are positioned at least partially within a shell. Each modular unit can be a fermentation unit, a pre-viral unit, a post-viral unit, a utility space, a warehouse, a media buffer facility, an office, a personnel unit, or another unit. The modular units can be arranged to maximize a number of modular units within the shell while minimizing a footprint of the shell. A method of assembling a facility for manufacturing at least one product includes providing at least one central unit and providing at least one modular unit in communication with the central unit(s) such that utilities are provided by the central unit(s) to the modular unit(s).
A recombinant eukaryotic host cell expressing a gene of interest (GOI) which is engineered by genetic modifications to increase expression of two or more genes encoding translation initiation factors (TIF genes) of the messenger ribonucleoprotein (mRNP), compared to the host cell prior to said one or more genetic modifications, wherein said TIF genes comprise at least a gene encoding eIF4A and a gene encoding eIF4G, and wherein expression of at least one of said TIF genes is under transcriptional control of a promoter different from the promoter controlling expression of said GOI..
C12N 15/79 - Vectors or expression systems specially adapted for eukaryotic hosts
C07K 14/47 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from animalsPeptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from humans from vertebrates from mammals
C12N 15/67 - General methods for enhancing the expression
C12N 15/81 - Vectors or expression systems specially adapted for eukaryotic hosts for fungi for yeasts
70.
ACETIC ACID AS PROCESSING AID IN SPRAY DRYING FOR BASIC DRUGS
01 - Chemical and biological materials for industrial, scientific and agricultural use
05 - Pharmaceutical, veterinary and sanitary products
40 - Treatment of materials; recycling, air and water treatment,
42 - Scientific, technological and industrial services, research and design
Goods & Services
Biological preparations, namely, genetically modified cells
and vectors for production of human, animal and synthetic
proteins, for clinical and commercial purposes in scientific
research and for use in pharmaceutical research. Biological preparations, namely, genetically modified cells
and genetically modified vectors for production of human,
animal and synthetic proteins for medical use and, for
clinical and commercial use in human and animal therapies. Manufacturing service, for the customer on behalf of and
according to the specifications of third parties, of
genetically modified cells and vectors for production of
human, animal and synthetic proteins, for clinical and
commercial use in scientific research and in pharmaceutical
research, as well as for clinical and commercial use in
human and animal therapies. Scientific and medical research in the field of
biotechnology; Technical consultancy and project planning in
the field of biological research relating to proteins;
research and development in the field of proteins for
others.
This invention discloses amorphous solid dispersions ASDs comprising darolutamide and a dispersion polymer, pharmaceutical dosage forms (PDF) comprising said ASD, such as capsules, tablets or caplets, and a method for preparing said ASDs.
BABRAHAM INSTITUTE ENTERPRISE, LTD. (United Kingdom)
PFIZER, INC. (USA)
Inventor
O'Callaghan, Peter M.
Bevan, Stephen
Young, Robert
Fraser, Peter
Zhang, Lin
Abstract
Mammalian cells are described that includes a recombination target site integrated within high integrating locus. Recombinant protein producer cell lines incorporating the mammalian cells and methods for forming the mammalian cells are also described. The high integrating loci have been developed through understanding and mapping of the three dimensional hierarchical structure of chromatin in mammalian cells. The high integrating loci are present in transcriptionally active environments that can provide both chromatin accessibility and epigenetic stability. As such, the recombinant mammalian cells can provide predictable and stable transgene production.
The invention concerns the field of container closure integrity (CCI) and the testing of CCI and relates to a device and a method for providing a displacement of a rubber stopper for leakage testing of a connection between the rubber stopper and a corresponding drug container which can be used for storing drugs under sterile conditions and which is closed by said rubber stopper.
G01M 3/22 - Investigating fluid tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point using special tracer materials, e.g. dye, fluorescent material, radioactive material for pipes, cables, or tubesInvestigating fluid tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point using special tracer materials, e.g. dye, fluorescent material, radioactive material for pipe joints or sealsInvestigating fluid tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point using special tracer materials, e.g. dye, fluorescent material, radioactive material for valves
G01M 3/28 - Investigating fluid tightness of structures by using fluid or vacuum by measuring rate of loss or gain of fluid, e.g. by pressure-responsive devices, by flow detectors for pipes, cables, or tubesInvestigating fluid tightness of structures by using fluid or vacuum by measuring rate of loss or gain of fluid, e.g. by pressure-responsive devices, by flow detectors for pipe joints or sealsInvestigating fluid tightness of structures by using fluid or vacuum by measuring rate of loss or gain of fluid, e.g. by pressure-responsive devices, by flow detectors for valves
75.
Carbon-source regulated protein production in a recombinant host cell
A recombinant host cell comprising an endogenous gene encoding a FLO8 protein comprising the amino acid sequence identified as SEQ ID NO:1 or a homologue thereof, which host cell is engineered by one or more genetic modifications to reduce expression of said gene compared to the host cell prior to said one or more genetic modifications, and which host cell comprises a heterologous expression cassette comprising a gene of interest (GO!) under the control of an expression cassette promoter (ECP) which ECP is repressible by a non-methanol carbon source, and a method of producing a protein of interest using said recombinant host cell.
The present invention relates to a displacement device, DD, for providing a displacement of a syringe closure system for a syringe relative to the syringe, a testing device, TD, and a method for leakage testing of a connection of a syringe closure system for a syringe with the syringe.
A61M 5/34 - Constructions for connecting the needle
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
G01M 3/04 - Investigating fluid tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point
01 - Chemical and biological materials for industrial, scientific and agricultural use
05 - Pharmaceutical, veterinary and sanitary products
09 - Scientific and electric apparatus and instruments
42 - Scientific, technological and industrial services, research and design
45 - Legal and security services; personal services for individuals.
Goods & Services
(1) Produits biochimiques, à savoir anticorps monoclonaux ou trimériques et leurs dérivés, pour la recherche et le développement scientifiques in vivo ou in vitro, pour le traitement du cancer, des maladies inflammatoires, des maladies auto-immunes, des maladies infectieuses et des maladies cardio-vasculaires et pour utilisation dans les laboratoires, pour le diagnostic et l'analyse pour la science ou pour la recherche.
(2) Préparations pharmaceutiques à base d'anticorps humains monoclonaux ou trimères et de leurs dérivés pour le traitement du cancer, des maladies inflammatoires, des maladies auto-immunes, des maladies infectieuses et des maladies cardiovasculaires et pour des utilisations diagnostiques ou thérapeutiques associées, et pour une utilisation dans des dosages associés.
(3) Logiciels pour la recherche scientifique en laboratoire et à usage commercial pour l'application d'anticorps monoclonaux ou trimériques au traitement du cancer, des maladies inflammatoires, des maladies auto-immunes, des maladies infectieuses et des maladies cardiovasculaires. (1) Recherche médicale et scientifique, ingénierie des protéines, développement de produits pharmaceutiques, recherche industrielle et recherche sous contrat, tous liés aux anticorps humains monoclonaux ou trimériques pour le traitement du cancer, des maladies inflammatoires, des maladies auto-immunes, des maladies infectieuses et des maladies cardiovasculaires; programmation informatique pour l'acquisition et le traitement de données médicales dans le cadre de la recherche, du développement et de la thérapie médico-scientifiques avec des anticorps monoclonaux ou trimériques et leurs dérivés.
(2) Services juridiques en matière d'exploitation de brevets, à savoir licence de brevets; octroi de licences de propriété intellectuelle dans le domaine des anticorps monoclonaux ou trimériques pour laboratoires, diagnostics et analyses à des fins scientifiques ou de recherche.
01 - Chemical and biological materials for industrial, scientific and agricultural use
05 - Pharmaceutical, veterinary and sanitary products
09 - Scientific and electric apparatus and instruments
42 - Scientific, technological and industrial services, research and design
45 - Legal and security services; personal services for individuals.
Goods & Services
Biochemicals, namely, monoclonal and trimeric antibodies and derivatives thereof for in-vivo or in-vitro scientific research and development to treat cancers, inflammatory diseases, autoimmune diseases, infectious diseases and cardiovascular diseases and for use in laboratories, diagnostics and analytics for scientific or research use Pharmaceutical preparations based on human monoclonal or trimeric antibodies and derivatives thereof for treating cancers, inflammatory diseases, autoimmune diseases, infectious diseases and cardiovascular diseases, for use in related diagnostic or therapeutic use, and for use as medical diagnostic assays for testing of body fluids or tissues, for use in disease detection, including, cancers, inflammatory diseases, autoimmune diseases, infectious diseases and cardiovascular diseases Downloadable computer software for scientific laboratory research and commercial use for applications with monoclonal or trimeric antibodies used to treat cancers, inflammatory diseases, autoimmune diseases, infectious diseases and cardiovascular diseases, namely, software for an algorithm to generate antibody sequences Medical and scientific research in the fields of human monoclonal or trimeric antibodies to treat cancers, inflammatory diseases, autoimmune diseases, infectious diseases and cardiovascular diseases; medical research services, namely, protein engineering in the fields of human monoclonal or trimeric antibodies to treat cancers, inflammatory diseases, autoimmune diseases, infectious diseases and cardiovascular diseases; pharmaceutical product development in the fields of human monoclonal or trimeric antibodies to treat cancers, inflammatory diseases, autoimmune diseases, infectious diseases and cardiovascular diseases; industrial research in the fields of human monoclonal or trimeric antibodies to treat cancers, inflammatory diseases, autoimmune diseases, infectious diseases and cardiovascular diseases; and contract research services in the fields of human monoclonal or trimeric antibodies to treat cancers, inflammatory diseases, autoimmune diseases, infectious diseases and cardiovascular diseases; computer programming for acquisition and processing of medical data in the context of medical-scientific research, development and therapy with monoclonal or trimeric antibodies and their derivatives Legal services in the field of patent exploitation, namely, patent licensing; licensing of intellectual property in the field of monoclonal and trimeric antibodies for laboratories, diagnostics and analytics for scientific or research use
79.
SPRAY DRYING OF SUPERSATURATED SOLUTIONS OF API WITH ACETIC ACID
The invention discloses a method for preparation of spray dried solid dispersions (SDD) comprising an active pharmaceutical ingredient (API) and a dispersion polymer (DISPPOL), wherein the spray drying is done with a supersaturated solution of API in a solvent mixture comprising two solvents, one is acetic acid, this supersaturated solution further comprising DISPPOL.
01 - Chemical and biological materials for industrial, scientific and agricultural use
05 - Pharmaceutical, veterinary and sanitary products
40 - Treatment of materials; recycling, air and water treatment,
42 - Scientific, technological and industrial services, research and design
Goods & Services
(1) Préparations biologiques, nommément, cosmides, plasmides d'ADN et chromosomes génétiquement modifiés pour la production de protéines humaines, animales et synthétiques dans le domaine de la recherche clinique, la recherche scientifique et la recherche pharmaceutique.
(2) Préparations biologiques, nommément, cosmides, plasmides d'ADN et chromosomes génétiquement modifiés pour la production de protéines humaines, animales et synthétiques à usage médical et clinique et thérapeutique pour les humains et animaux. (1) Service de fabrication au client pour le compte et selon les spécifications de tiers de cellules et de vecteurs génétiquement modifiés pour la production de protéines humaines, animales et synthétiques, pour l'usage clinique et commerciale dans la recherche scientifique et dans la recherche pharmaceutique, ainsi que pour l'usage clinique et commerciale de la thérapie humaine et animale.
(2) Recherche scientifique et médicale dans le domaine de la biotechnologie; consultation technique et planification de projets dans le domaine de la recherche biologique concernant les protéines; recherche et développement pour des tiers dans le domaine des protéines.
40 - Treatment of materials; recycling, air and water treatment,
01 - Chemical and biological materials for industrial, scientific and agricultural use
05 - Pharmaceutical, veterinary and sanitary products
42 - Scientific, technological and industrial services, research and design
Goods & Services
Manufacturing services for others in the field of genetically modified cells and vectors for production of human, animal and synthetic proteins for use in scientific research, for use in pharmaceutical research and for clinical and commercial use, as well as for clinical and commercial use in human and animal therapies Biological preparations, namely, genetically modified cells and genetically modified vectors for production of human, animal and synthetic proteins for use in clinical and commercial scientific research and for use in pharmaceutical research Biological preparations, namely, genetically modified cells and genetically modified vectors for production of human, animal and synthetic proteins for medical and veterinary use, namely, for use in clinical and commercial human and animal therapies Scientific and medical research in the field of biotechnology and life sciences; technical consultancy and technical project planning, namely, establishing scientific and medical research protocols and protein engineering pathways and scientific and medical research processes in the field of biological research relating to proteins; research and development in the field of proteins
A method of reducing precipitation in a bacterial fermentation process for producing a fermentation product, which fermentation process comprises the steps: a) cultivating the host cells for bacterial growth in a batch phase using a batch medium; and b) cultivating the host cells for producing the fermentation product in a fedbatch phase using a feed medium; which feed and batch media are each unprecipitated media solutions, wherein: i) the batch medium comprises an amount of calcium salts, magnesium salts, phosphate salts and at least one chelating agent, which is a citrate salt and/or citric acid at an amount of at least 5 mM, and/or EDTA at an amount of at least 1 mM; and ii) the feed medium comprises an amount of calcium salts which is at least 1 mM, and which is at least 5-fold higher as compared to the batch medium (M/M); and iii) the feed medium comprises an amount of magnesium salts which is at least 3 mM, and which is at least 2-fold higher as compared to the batch medium (M/M); and iv) the feed medium comprises an amount of phosphate salts which is less than 90% of the amount comprised in the batch medium (M/M).
A method of reducing precipitation in a bacterial fermentation process for producing a fermentation product, which fermentation process comprises the steps: a) cultivating the host cells for bacterial growth in a batch phase using a batch medium; and b) cultivating the host cells for producing the fermentation product in a fedbatch phase using a feed medium; which feed and batch media are each unprecipitated media solutions, wherein: i) the batch medium comprises an amount of calcium salts, magnesium salts, phosphate salts and at least one chelating agent, which is a citrate salt and/or citric acid at an amount of at least 5 mM, and/or EDTA at an amount of at least 1 mM; and ii) the feed medium comprises an amount of calcium salts which is at least 1 mM, and which is at least 5-fold higher as compared to the batch medium (M/M); and iii) the feed medium comprises an amount of magnesium salts which is at least 3 mM, and which is at least 2-fold higher as compared to the batch medium (M/M); and iv) the feed medium comprises an amount of phosphate salts which is less than 90% of the amount comprised in the batch medium (M/M).
The invention concerns the field of container closure integrity (CCI) and the testing of CCI and relates to a device and a method for leakage testing of a connection between a rubber stopper and a corresponding drug container which can be used for storing drugs under sterile conditions and which is closed by said rubber stopper.
G01M 3/22 - Investigating fluid tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point using special tracer materials, e.g. dye, fluorescent material, radioactive material for pipes, cables, or tubesInvestigating fluid tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point using special tracer materials, e.g. dye, fluorescent material, radioactive material for pipe joints or sealsInvestigating fluid tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point using special tracer materials, e.g. dye, fluorescent material, radioactive material for valves
G01M 3/20 - Investigating fluid tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point using special tracer materials, e.g. dye, fluorescent material, radioactive material
G01M 3/18 - Investigating fluid tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point using electric detection means for pipes, cables, or tubesInvestigating fluid tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point using electric detection means for pipe joints or sealsInvestigating fluid tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point using electric detection means for valves
G01M 3/00 - Investigating fluid tightness of structures
Provided are viral vector formulations comprising a globular protein such as an albumin. Also provided are viral vector formulations comprising a polysaccharide such as an hyaluronic acid. The provided viral vector formulations have increased stability and reduced viral vector aggregation.
This invention discloses amorphous solid dispersions ASD comprising acalabrutinib and HPMCAS, oral dosage forms comprising said ASD, such as capsules, tablets or caplets, and a method for preparing said ASDs.
Provided are viral vector formulations comprising a globular protein such as an albumin. Also provided are viral vector formulations comprising a polysaccharide such as an hyaluronic acid. The provided viral vector formulations have increased stability and reduced viral vector aggregation.
The present disclosure provides a method of determining the concentration of a polysorbate, the method comprising providing a composition comprising a protein and the polysorbate, adding a second surfactant to the composition, wherein the concentration of the second surfactant in the composition is below the critical micelle concentration (CMC) of the second surfactant, and wherein the second surfactant has a CMC mass value higher than the polysorbate CMC mass value, precipitating the protein in the composition to form a precipitate and a supernatant, and determining the concentration of the polysorbate in the supernatant using a fluorescent micelle assay.
01 - Chemical and biological materials for industrial, scientific and agricultural use
Goods & Services
Marine-phytoplankton-based chemicals for use in dietary and nutritional supplements sold as bulk ingredients for subsequent product formulation on a business-to-business basis
90.
METHODS FOR IMPROVING PRODUCTION OF BIOLOGICAL PRODUCTS BY REDUCING THE LEVEL OF ENDOGENOUS PROTEIN
The present disclosure features methods, cells or cell lines, and compositions for increasing the amount of products, e.g., proteins, produced by a cell or cell line by reducing the level of a non-essential endogenous protein.
The invention discloses a method for preparation of polyoxyethylene 1,4-sorbitan fatty acid ester, such as Polysorbate 80, by a reaction of polyoxyethylene 1,4-sorbitan with a fatty acid chloride, and polyoxyethylene 1,4-sorbitan fatty acid esters obtainable by this method.
C08G 65/332 - Polymers modified by chemical after-treatment with organic compounds containing oxygen containing carboxyl groups, or halides or esters thereof
A method for producing of a protein of interest (POI) in a yeast host cell that is modified to comprise within one or more expression cassettes heterologous nucleic acid molecules encoding helper factors and a gene of interest (GOI) encoding the POI, wherein: a) a first helper factor comprises at least 90% sequence identity to SEQ ID NO:1; b) a second helper factor comprises at least 90% sequence identity to SEQ ID NO:3; and c) a third helper factor comprises at least 90% sequence identity to SEQ ID NO:5; which method comprises (i) culturing said host cell in a culture medium under conditions to co-express said heterologous nucleic acid molecules and to secrete said POI into the host cell culture; and (ii) recovering the POI from the host cell culture.
The present invention is in the field of recombinant biotechnology, in particular in the field of protein expression. The invention generally relates to a method of expressing a protein of interest (POI) from a host cell. The invention relates particularly to improving a host cell's capacity to express and/or secrete a protein of interest and use of the host cell for protein expression. The invention also relates to cell culture technology, and more specifically to culturing cells to produce desired molecules for medical purposes or food products.
The present disclosure is directed to a big-bag transfer station for API seed crystals. The transfer station may permit the filling of smaller containers, such as bags or pouches, from a large container, such as a big bag. The transfer station may permit the transfer without contaminating the atmosphere of the room in which the station is housed. Additionally, the transfer station may limit cross-contamination between filling cycles by employing single-use liners.
The present invention is in the field of recombinant biotechnology, in particular in the field of protein expression. The invention generally relates to a method of increasing the yield of a protein of interest (POI) in a eukaryotic host cell, preferably a yeast, by overexpressing at least one polynucleotide encoding at least one transcription factor of the present invention, preferably Msn4/2. The invention relates further to a recombinant eukaryotic host cell for manufacturing a POI, wherein the host cell is engineered to overexpress at least one polynucleotide encoding at least one transcription factor as well as the use of the host cell for manufacturing a POI.
The invention discloses a method for preparation of 1,4-sorbitan by dehydration of D-sorbitol, wherein one equivalent of water is removed and a cyclization occurs, followed by a treatment with ethanol and isopropanol.
A filtration system can include a loading member configured to receive a plurality of filtration members which can be sequentially moved from a non-active position in which a respective one of the plurality of filtration members is not in fluid communication with a sample flow path of the cell removal system, to an active position in which the respective filtration member is in fluid communication with the sample flow path, and to a discarded position in which the respective filtration member has been removed from fluid communication with the sample flow path.
The present disclosure provides a method of purifying polysaccharides from a cell lysate, comprising partially purifying the cell lysate comprising an impurity and a polysaccharide to obtain a clarified crude lysate; mixing the clarified crude lysate with a neutralization solution comprising a salt to form a neutralized lysate; mixing the neutralized lysate with a precipitation solution comprising cetyltrimethylammonium bromide to form a first supernatant and a first precipitate; and separating the first precipitate from the first supernatant, wherein the polysaccharide is located in the first supernatant. The present disclosure further provides a method of making a polysaccharide vaccine. Also provided are vaccines, delivery systems, compositions and polysaccharides made by the methods described herein.
The present disclosure provides a method of purifying polysaccharides from a cell lysate, comprising partially purifying the cell lysate comprising an impurity and a polysaccharide to obtain a clarified crude lysate; mixing the clarified crude lysate with a neutralization solution comprising a salt to form a neutralized lysate; mixing the neutralized lysate with a precipitation solution comprising cetyltrimethylammonium bromide to form a first supernatant and a first precipitate; and separating the first precipitate from the first supernatant, wherein the polysaccharide is located in the first supernatant. The present disclosure further provides a method of making a polysaccharide vaccine. Also provided are vaccines, delivery systems, compositions and polysaccharides made by the methods described herein.