Softgel capsules comprise a fill composition and a shell composition, wherein the fill composition includes valproic acid and the shell composition includes gelatin, a plasticizer, and an enteric polymer. The softgel capsules further include from 125 mg to 1000 mg dosing of valproic acid. A method for producing the softgel capsule using a gel mass and rotary die encapsulation is also provided.
The present disclosure provides antibody-drug conjugate structures, which include a cleavable linker that links the antibody to the drug and has a first enzymatically cleavable moiety and a second enzymatically cleavable moiety which includes a glycoside selected from a galactoside, a glucoside, a mannoside, a fucoside, O-GlcNAc, and O-GalNAc. The disclosure also encompasses compounds and methods for production of such conjugates, as well as methods of using the conjugates.
C07K 5/062 - Dipeptides the side chain of the first amino acid being acyclic, e.g. Gly, Ala
A61K 47/68 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
A compressed mass is provided including a marking formulation including a marking component. The marking component includes a metal oxide. Laser irradiation is applied to the tablet at a wavelength of about 200 nm to about 400 nm, causing the marking component to change color. A method of marking and marking formulation is also provided.
Disclosed herein are methods, systems, and kits for determining the total amount of a coating polymer in a dosage form. The coating polymer may be a polydisperse polymer having a plurality of molecular weights. The instant disclosure enables to accurately, reliably, and efficiently determine the total amount of a polydisperse polymer in a dosage form that includes one or more other constituents that have a molecular weight range that overlap with at least some of the polydisperse polymer's molecular weight.
The present disclosure provides antibody conjugates (e.g., antibody-drug conjugates (ADCs)) specific for MUC1. The disclosure also encompasses methods of production of such conjugates, as well as methods of using the same. Also provided are compositions that include the ADC of the present disclosure, including in some instances, pharmaceutical compositions. In certain aspects, provided are methods of using the ADC that include administering to an individual having a cell proliferative disorder a therapeutically effective amount of the ADC of the present disclosure.
A61K 47/68 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
C07K 16/30 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
6.
CAPSULES FOR ORAL AND NASAL DELIVERY OF PHARMACEUTICAL PRODUCTS
Disclosed herein is a method including administering a pharmaceutical composition. The administering includes dispensing a pharmaceutical fill composition comprising an active agent from a softgel capsule to the nasal cavity of a patient for nasal absorption or to the oral cavity of the patient for pre-gastric absorption.
The present disclosure provides anti-TACSTD2 (Tumor Associated Calcium Signal Transducer 2) antibody-maytansine conjugate structures. The disclosure also encompasses methods of production of such conjugates, as well as methods of using the conjugates, such as methods of treating cancer using the subject conjugates. In addition, the disclosure encompasses anti-TACSTD2 antibodies, as well as methods of making the subject anti-TACSTD2 antibodies.
A61K 47/68 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
A61P 35/04 - Antineoplastic agents specific for metastasis
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
8.
Antibody-Drug Conjugates and Methods of Use Thereof
The present disclosure provides antibody conjugates (e.g., antibody-drug conjugates (ADCs)). The disclosure also encompasses methods of production of such conjugates, as well as methods of using the same. Also provided are compositions that include the ADC of the present disclosure, including in some instances, pharmaceutical compositions. In certain aspects, provided are methods of using the ADC that include administering to an individual a therapeutically effective amount of the ADC of the present disclosure.
A61K 47/68 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
Disclosed herein is a method for preparing a softgel capsule including treating a softgel capsule with a solution including a calcium salt, wherein the softgel capsule includes a fdl material and a shell composition including pectin.
The present disclosure provides antibodies specific for Nectin-4 and antibody conjugates e.g., antibody-drug conjugates (ADCs), comprising such antibodies. The disclosure also encompasses methods of production of such antibodies and antibody conjugates, as well as methods of using the same. Also provided are compositions that include the antibodies and antibody conjugates of the present disclosure, including in some instances, pharmaceutical compositions. In certain aspects, provided are methods of using the ADC that include administering to an individual having a cell proliferative disorder a therapeutically effective amount of the antibodies or antibody conjugates of the present disclosure.
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
A61K 47/68 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
Disclosed in certain embodiments is a softgel capsule including a fill material including ibuprofen or a pharmaceutically acceptable salt thereof, and a shell composition comprising a non-gelatin biobased polymer, the film completely dissolving in less than 30 minutes when subject to a dissolution with a USP Apparatus I at 75 - 200 rpm of basket speed or a USP Apparatus II with paddle speed at 75 RPM in 900 ml of 50 mM phosphate buffer (pH 7.2) and deionized water at 37 degrees C.
The present disclosure provides cleavable linkers for antibody-drug conjugates (ADCs) where the linker includes a tandem-cleavage moiety. The present disclosure also provides ADCs including the cleavable linkers having the tandem-cleavage moiety. In addition, the present disclosure encompasses compounds and methods for production of such ADCs, as well as methods of using the ADCs.
The present disclosure provides antibody-drug conjugate (ADC) structures, which include an antibody, a first drug attached to the antibody at a native amino acid residue of the antibody through a first linker, and a second drug attached to the antibody at a site-specifically engineered conjugation site of the antibody through a second linker. The disclosure also encompasses compounds and methods for production of such conjugates, as well as methods of using the conjugates.
A61K 47/68 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
C07K 16/30 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
14.
ANTIBODY SPECIFIC FOR MUCIN-1 AND METHODS OF USE THEREOF
The present disclosure provides antibodies specific for Mucin 1. Nucleic acids that encode one or both of the variable chains of an antibody of the present disclosure are also provided, as are cells that include such nucleic acids. Also provided are compositions that include the antibodies of the present disclosure, including in some instances, pharmaceutical compositions. Methods of making and using the antibodies of the present disclosure are also provided. In certain aspects, provided are methods that include administering to an individual having a cell proliferative disorder a therapeutically effective amount of an antibody of the present disclosure, where the antibody is administered to the individual to enhance an immune response, e.g., a T cell response, to abnormally proliferating cells of the cell proliferative disorder. The antibodies are also useful in various diagnostic, and monitoring applications, which are also provided.
C07K 16/30 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
A61K 39/00 - Medicinal preparations containing antigens or antibodies
A61K 47/69 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
Embodiments of the present disclosure include systems and methods for generating an executable batch record for a clinical trial study. The method includes displaying a user interface for having a production user input batch record information comprising via a production user interface (UI), and receiving packaging instructions, a bill of materials, and a lot assignment from the production user. The method further includes producing a preliminary batch record based on the information input by the production user. The method further displaying a customer UI that includes the preliminary batch record and an interface for approving the preliminary batch record, and receiving an approval of the preliminary batch record from a customer user. The method further includes producing an executable batch record for a producer to execute upon customer approval.
G06Q 10/0875 - Itemisation or classification of parts, supplies or services, e.g. bill of materials
G16H 10/20 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for electronic clinical trials or questionnaires
16.
SOFTGEL CAPSULE INCLUDING A NON-STEROIDAL ANTI-INFLAMMATORY DRUG AND ACETAMINOPHEN
Described herein is a softgel capsule including a fill material and a shell composition. The fill material may include an alkali metal salt of a NSAID. acetaminophen and does not include povidone. The shell composition may include a film forming material. The softgel capsule may have an assay stability of at least about 99% at room temperature after 12 months.
A61K 31/165 - Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
A61K 31/167 - Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen atom of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
17.
SOFTGEL CAPSULE INCLUDING A NON-STEROIDAL ANTI-INFLAMMATORY DRUG AND ACETAMINOPHEN
Described herein is a softgel capsule including a fill material and a shell composition. The fill material may include an alkali metal salt of a NSAID, acetaminophen and potassium acetate. The shell composition may include a film forming material. The softgel capsule may have a stability of at least about 90%, at least about 92%, at least about 95%, at least about 97%, or at least about 99% at room temperature after 1 month.
A61K 31/167 - Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen atom of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
Disclosed in certain embodiments is a softgel capsule film comprising a non-gelatin biobased polymer, the film completely dissolving in less than 30 minutes when subject to a dissolution with a USP Apparatus II with paddles at 75 RPM in 900 ml of 0.1N HCL and deionized water at 37 degrees C.
A method of treating a hard capsule shell to reduce or alleviate stress or reduce the propensity for cracking in the capsule shell. The method includes a step of heating at least a portion of the hard capsule shell to a temperature above a glass transition temperature of the capsule shell but below a melt temperature of the hard capsule shell for a time sufficient to reduce internal stress in the hard capsule shell. The method can be used to reduce cracking of hard capsule shells by application of the heat treatment to the filled capsule shells after fabrication and filling.
A61J 3/07 - Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate
F26B 3/02 - Drying solid materials or objects by processes involving the application of heat by convection, i.e. heat being conveyed from a heat source to the materials or objects to be dried by a gas or vapour, e.g. air
F26B 21/00 - Arrangements for supplying or controlling air or gases for drying solid materials or objects
F26B 21/04 - Circulating air or gases in closed cycles, e.g. wholly within the drying enclosure partly outside the drying enclosure
Softgel capsules comprise a fill material and a shell composition, wherein the fill composition includes bisacodyl and the shell composition includes a film forming material and an enteric polymer. The softgel capsules further include 5 parts by weight of bisacodyl based on 100 parts by weight of the fill material. A method for producing the softgel capsule using a gel conversion is also provided.
The present invention relates AAV genomes, vectors and nucleic acids containing variant capsid protein sequences that allow for increased titer, along with improved packing during recombinant AAV vector particle production. Titers improved several fold, without a similar increase in residual packaged hcDNA, along with maintaining percent full capsid ratio. In addition viral proteins expression and ratios remained unchanged with the variants.
Disclosed herein is a softgel capsule including a fill material, shell composition and a coating having an enteric polymer, wherein the coating provides about 1% to about 10% weight gain of the capsule. The coating improves the robustness of enteric property and minimized the moisture absorption during dissolution of the softgel capsule.
Disclosed in certain embodiments is a delayed release softgel capsules comprise a fill material that is encapsulated in a pH dependent shell composition, the pH dependent shell composition including pectin and gellan gum. Also disclosed are methods of preparing any of the delayed release softgel capsules described herein and methods of use thereof.
A23L 29/269 - Foods or foodstuffs containing additivesPreparation or treatment thereof containing gelling or thickening agents of microbial origin, e.g. xanthan or dextran
Disclosed in certain embodiments is a liquid formulation for oral administration comprising an amphiphilic material and ambroxol or a pharmaceutically acceptable salt thereof.
A61K 47/14 - Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
A61K 47/24 - Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
Enteric softgel capsules comprise a fill material and an enteric shell composition. characterized in that the enteric nature of the capsules may be achieved without an enteric coating or added conventional enteric polymers.
Methods for reducing cleavage of a protein comprising a formylglycine (fGly) amino acid is provided. Such methods can involve protecting the protein from exposure to visible light having a wavelength of 500 nm or lower. Also provided herein are methods for inducing cleavage of a protein in a target region, the target region comprising an fGly amino acid. The methods may involve exposing the protein to visible light comprising a wavelength of 300 nm-500 nm in the presence of a flavin. Cleavage of the protein may be carried out in the presence of a molecule that is photoactivated to release singlet oxygen species. Cleavage of the protein may be carried out in the presence of a flavin.
G16H 10/20 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for electronic clinical trials or questionnaires
G16H 40/20 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
29.
Anti-CD25 Antibody-Maytansine Conjugates and Methods of Use Thereof
The present disclosure provides anti-CD25 antibody-maytansine conjugate structures. The disclosure also encompasses methods of production of such conjugates, as well as methods of using the same.
A61K 47/65 - Peptidic linkers, binders or spacers, e.g. peptidic enzyme-labile linkers
A61K 47/68 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
The present invention relates to methods for the size-based separation and analysis of nucleic acids, in particular for integrity characterization and impurity detection in RNA preparations intended for use as biopharmaceuticals.
C12N 15/10 - Processes for the isolation, preparation or purification of DNA or RNA
B01J 20/28 - Solid sorbent compositions or filter aid compositionsSorbents for chromatographyProcesses for preparing, regenerating or reactivating thereof characterised by their form or physical properties
C07H 1/08 - SeparationPurification from natural products
C07H 21/02 - Compounds containing two or more mononucleotide units having separate phosphate or polyphosphate groups linked by saccharide radicals of nucleoside groups, e.g. nucleic acids with ribosyl as saccharide radical
C07H 21/04 - Compounds containing two or more mononucleotide units having separate phosphate or polyphosphate groups linked by saccharide radicals of nucleoside groups, e.g. nucleic acids with deoxyribosyl as saccharide radical
C12Q 1/68 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving nucleic acids
The present disclosure provides antibody-drug conjugate structures, that include cleavable linker having a sulfatase-cleavable moiety. The disclosure also encompasses methods of production of such conjugates, as well as methods of using the same.
A61K 47/68 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
The present disclosure provides binding agents, particularly, antibodies, that comprise variable regions comprising humanized framework regions. Nucleic acids that encode one or both of the variable chains of the binding agents of the present disclosure are also provided, as are cells that include such nucleic acids. Also provided are compositions, including in some instances, pharmaceutical compositions, that include the binding agents disclosed herein. Methods of making and using the binding agents of the present disclosure are also provided. In certain aspects, provided are methods that include administering to an individual having a cell proliferative disorder a therapeutically effective amount of a binding agent disclosed herein, where the binding agent is administered to the individual to enhance an immune response, e.g., a T cell response, to abnormally proliferating cells. The binding agents are also useful in various diagnostic, and monitoring applications, which are also provided.
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
A61K 47/54 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic compound
A61K 47/68 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
A user interface (UI) for providing optimized parameters for a fluid bed granulation process may include a first user input field for receiving intrinsic properties of an input powder, a second user input field for receiving granulation requirements for granules formed from the input powder during the fluid bed granulation process, a third user input field for receiving operational capabilities of a fluid bed granulation system, and an output field configured to display optimal process parameters for the fluid bed granulation system. The optimal process parameters may be determined by thermodynamically modeling granulation of the input powder in the fluid bed granulation system.
B01J 2/16 - Processes or devices for granulating materials, in generalRendering particulate materials free flowing in general, e.g. making them hydrophobic by suspending the powder material in a gas, e.g. in fluidised beds or as a falling curtain
G06F 30/28 - Design optimisation, verification or simulation using fluid dynamics, e.g. using Navier-Stokes equations or computational fluid dynamics [CFD]
34.
SYSTEMS AND METHODS FOR PROVIDING OPTIMAL PROCESS PARAMETERS FOR FLUID BED GRANULATION SYSTEMS
A user interface (UI) for providing optimized parameters for a fluid bed granulation process may include a first user input field for receiving intrinsic properties of an input powder, a second user input field for receiving granulation requirements for granules formed from the input powder during the fluid bed granulation process, a third user input field for receiving operational capabilities of a fluid bed granulation system, and an output field configured to display optimal process parameters for the fluid bed granulation system. The optimal process parameters may be determined by thermodynamically modeling granulation of the input powder in the fluid bed granulation system.
B01J 2/16 - Processes or devices for granulating materials, in generalRendering particulate materials free flowing in general, e.g. making them hydrophobic by suspending the powder material in a gas, e.g. in fluidised beds or as a falling curtain
Provided are humidity control devices, systems, and methods of controlling humidity in an enclosed container. A humidity control device can comprise a cap configured to attach to a container; a first tubular member passing through the cap to form a first portion of the first tubular member and a second portion of the first tubular member, the first portion comprising a proximal end extending away from the cap and the second portion comprising an inlet configured to receive a fluid, wherein when the cap is attached to the container, the first portion is within the container and the second portion is outside of the container, wherein the proximal end of the first tubular member comprises an outlet for delivering the fluid to an interior space of the container.
This disclosure provides methods of using antibody-drug-conjugates of formula (I). Specifically, the disclosure provides methods of reducing target-mediated cross-reactivity by using the antibody-drug-conjugates (ADCs) of formula (I). The disclosure also includes methods of using such conjugates in a variety of therapeutic indications, as well as methods of production of such conjugates.
A61K 47/68 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
A softgel capsule is provided which can be used with a fill composition including a high alcohol content. The softgel capsule includes a shell composition including a film forming polymer and a plasticizer. The fill composition includes at least about 20 wt. % alcohol. The softgel capsule has a weight loss change of less than about 10% after 30 days, 90 days, 6 months, 9 months or 12 months storage at ambient conditions.
The invention provides a method of producing a population of CD73+CD44+, CD90+mesenchymal stromal cells (MSCs). The CD73+CD44+, CD90+ MSCs are used in methods of generating terminally differentiated osteogenic, adipogenic and chondrogenic cells from pluripotent stem cells (PSCs). The differentiation method includes the use of a single agent, WNT signaling pathway activator such as a GSK3β inhibitor, used on adherent culture of PSCs.
Provided are pharmaceutical compositions and methods for preparing pharmaceutical compositions comprising wax coated tablets. Specifically, a wax coating can be applied to a pharmaceutical tablet prior to the film coating process.
A61K 31/4545 - Non-condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a six-membered ring with nitrogen as a ring hetero atom, e.g. pipamperone, anabasine
Disclosed in certain embodiments is a capsule comprising a liquid fill material comprising an osmogen and an active agent; and a semi-permeable disintegration resistant shell composition.
The present disclosure provides anti-CD37 antibodies and anti-CD37 antibody-maytansine conjugate structures. The disclosure also encompasses methods of production of such antibodies and conjugates, as well as methods of using the same.
A61K 47/68 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
42.
MORE PRODUCTS. BETTER TREATMENTS. RELIABLY SUPPLIED.
39 - Transport, packaging, storage and travel services
42 - Scientific, technological and industrial services, research and design
Goods & Services
Business consulting services relating to product distribution, operations management services, logistics, reverse logistics, supply chain, and production systems and distribution solutions; business management services, namely, managing logistics, reverse logistics, supply chain services, supply chain visibility and synchronization, supply and demand forecasting and product distribution processes for others; business consulting services in the field of commercialization of pharmaceutical products; distributorship services in the field of pharmaceuticals, biopharmaceuticals, radiopharmaceuticals, health care products and medical products; invoicing services; order fulfillment services; customer services, namely responding to customer inquiries for others in the field of pharmaceutical product distribution and logistics via telephone or other electronic means; electronic customer online ordering services for pharmaceuticals, pharmaceutical products, medical products and equipment, laboratory supplies and equipment; computerized pharmaceutical record-keeping for regulatory compliance and inventory control purposes; pharmaceutical inventory control services; inventory management in the field of pharmaceuticals and pharmaceutical products; computerized tracking and tracing of packages in transit for business purposes; operation of a telephone call center for others to assist in locating and delivering complex pharmaceuticals and radiopharmaceuticals Packaging of clinical, pharmaceutical and health care products to the order and specification of others Pharmaceutical and biopharmaceutical drug development services; pharmaceutical and biopharmaceutical research and development; development of pharmaceuticals, biopharmaceuticals, radiopharmaceuticals, pharmaceutical preparations, vitamins, medicines, pharmaceutical packaging and drug delivery technologies; research and development of new products for others; product development consultation; product research services, namely, providing analytical testing, biosafety testing, reporting and laboratory services for others; Scientific consulting and research services for the pharmaceutical industry; Technical consulting for the pharmaceutical industry in the field of new drug development; consultation in the field of pharmaceutical drug delivery and dosage technologies; custom design and development of chemical reagents and biochemical assays
43.
Dual-Cleavage Ester Linkers for Antibody-Drug Conjugates
The present disclosure provides antibody-drug conjugate structures, where the antibody-drug conjugate includes a cleavable linker containing an ester group that links the antibody to the drug. The disclosure also encompasses compounds and methods for production of such conjugates. In addition, the disclosure also encompasses pharmaceutical compositions and methods of using the conjugates.
A61K 47/68 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
44.
SOFTGEL CAPSULES AND A METHOD FOR PREPARING THE SOFTGEL CAPSULES
Disclosed herein is a method for preparing a softgel capsule including treating a soflgel capsule with a solution including a calcium salt, wherein the softgel capsule includes a fdl material and a shell composition including pectin.
Disclosed herein are dosage forms including a fill material that incorporates an anionic chelating agent, such as lecithin, and a salt form of a basic or acidic active pharmaceutical ingredient and a free ion. The molar ratio of the anionic chelating agent, such as lecithin, to the free ion ranging from about 0.5 to about 3. Also disclosed herein are methods of stabilizing dosage forms that include a salt form of a basic or acidic active pharmaceutical ingredient, methods of preparing such dosage forms, and methods of using such dosage forms.
A softgel capsule is provided including a fill material and a shell composition. The shell composition includes a marking formulation including a marking component. The marking component includes a metal oxide. Laser irradiation may be applied to the softgel capsule at a wavelength of about 200 nm to about 400 nm, causing the marking component to change color. A method of marking and marking formulation is also provided.
A softgel capsule is provided including a fill material and a shell composition The shell composition includes a marking formulation including a marking component. Tire marking component includes a metal oxide. Laser irradiation is applied to the softgel capsule at a wavelength of about 1000 nm to about 2200 nm, causing the marking component to cause a visible effect. A method of marking and marking formulation is also provided.
A61J 3/07 - Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
A softgel capsule is provided including a fill material and a shell composition The shell composition includes a marking formulation including a marking component. The marking component includes a metal oxide. Laser irradiation is applied to the softgel capsule at a wavelength of about 1000 nm to about 2200 nm, causing the marking component to cause a visible effect. A method of marking and marking formulation is also provided.
A softgel capsule is provided including a fill material and a shell composition The shell composition includes a marking formulation including a marking component. The marking component includes a metal oxide. Laser irradiation may be applied to the softgel capsule at a wavelength of about 200 nm to about 400 nm, causing the marking component to change color. A method of marking and marking formulation is also provided.
The present disclosure provides antibody-drug conjugate structures. The antibody-drug conjugate structures include a branched linker where two or more payloads per branched linker are attached to a polypeptide (e.g., an antibody). In addition, the disclosure also encompasses compounds and methods for production of such conjugates. In addition, the disclosure also encompasses methods of using the conjugates.
A61K 47/64 - Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
A61K 31/7056 - Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing five-membered rings with nitrogen as a ring hetero atom
A61K 31/706 - Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom
Embodiments of the present disclosure include systems and methods for confidentially producing shipment orders for clinical trials. The method includes receiving a plurality of supply orders associated with one or more clinical trials and determining a clinical trial study, a site location, and a treatment type. A first plurality of supply orders are assigned to a packaging site based on the site location. The method further includes, associating a first sub-group of the first plurality of supply orders with a first assembly procedure, associating a second sub-group of the plurality of supply orders with a second assembly procedure, and assigning, randomly, the plurality of kit identifiers to the first sub-group and the second subgroup, thereby creating a plurality of blinded kits. The method further includes confidentially producing shipment orders for the first plurality of clinical trials based on the plurality of blinded kits.
G16H 10/20 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for electronic clinical trials or questionnaires
B65B 65/00 - Details peculiar to packaging machines and not otherwise provided forArrangements of such details
G06Q 10/087 - Inventory or stock management, e.g. order filling, procurement or balancing against orders
G16H 20/10 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
52.
Antibody Conjugates and Methods of Making and Using the Same
Antibodies that include a sulfatase motif-containing tag in a constant region of an immunoglobulin (Ig) light chain polypeptide are disclosed. The sulfatase motif can be converted by a formylglycine-generating enzyme (FGE) to produce a formylglycine (fGly)-modified Ig light chain polypeptide. An fGly-modified Ig light chain polypeptide of the antibody can be covalently and site-specifically bound to a moiety of interest to provide an antibody conjugate. The disclosure also encompasses methods of production of such tagged Ig light chain polypeptides, fGly-modified Ig light chain polypeptides, and antibody conjugates, as well as methods of use of same.
A61K 47/60 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
A61K 47/68 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
C07K 16/00 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies
C07K 16/30 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
53.
NON-ANIMAL SOFTGEL CAPSULE FORMULATIONS, METHODS OF PREPARATION, AND METHODS OF USE THEREOF
Disclosed in certain embodiments is a softgel composition comprising a fill material encapsulated in a shell composition. The shell composition having a non-animal derived gelling agent and a water soluble polymer. The shell composition completely dissolving in less than 30 minutes when subject to a dissolution with a USP Apparatus II with paddies at 75 RPM in 900 ml of 0.1N HCL and deionized water at 37 degrees C.
The invention provides a method of producing a population of CD34+hematopoietic precursor cells. The CD34+ hematopoietic precursor cells are used in methods of producing natural killer (NK), methods of inducing NK cell differentiation from pluripotent stem cells (PSCs), and methods of generating terminally differentiated hematopoietic cells from PSCs. The differentiation of immune cells such as NK cells from PSCs includes the use of a hemogenic endothelium induction cocktail that includes a WNT signaling pathway activator, a bone morphogenetic protein and/or a vascular endothelial growth factor. Also provided is a method of producing hematopoietic stem cells from pluripotent stem cells.
Disclosed in certain embodiments is a softgel capsule film comprising a non-gelatin biobased polymer, the film completely dissolving in less than 30 minutes when subject to a dissolution with a USP Apparatus II with paddles at 75 RPM in 900 ml of 0.1N HCL and deionized water at 37 degrees C.
Disclosed herein is a softgel capsule including a fill material, shell composition and a coating having an enteric polymer, wherein the coating provides about 1% to about 10% weight gain of the capsule. The coating improves the robustness of enteric property and minimized the moisture absorption during dissolution of the softgel capsule.
Disclosed in certain embodiments is a softgel capsule film comprising a non-gelatin biobased polymer, the film completely dissolving in less than 30 minutes when subject to a dissolution with a USP Apparatus II with paddles at 75 RPM in 900 ml of 0.1N HCL and deionized water at 37 degrees C.
Softgel capsules comprise a fill material and a shell composition, wherein the fill composition includes bisacodyl and the shell composition includes a film forming material and an enteric polymer. The softgel capsules further include 5 parts by weight of bisacodyl based on 100 parts by weight of the fill material. A method for producing the softgel capsule using a gel conversion is also provided.
Delayed release softgel capsules including a fill material and a pH dependent shell composition. In one embodiments, the pH dependent shell composition includes gelatin, pectin, dextrose, and from about 0.5 wt % to about 10 wt % of a synthetic polymer. In an alternative embodiment, the pH dependent shell composition includes gelatin, pectin, dextrose, and an organic acid. The delayed release nature of the capsules inhibits premature release of the fill material in acidic pHs (such as pH of from any of about 1.2 to about 6).
Delayed release softgel capsules including a fill material and a pH dependent shell composition. In one embodiments, the pH dependent shell composition includes gelatin, pectin, dextrose, and a combination of glycerin and sorbitol or sorbitol sorbitan solution. The delayed release nature of the capsules meets enteric disintegration criteria and/or inhibits premature release of the fill material in acidic pHs (such as pH of from any of about 1.2 to about 6).
Softgel capsules comprise a fill material and a shell composition, wherein the fill composition includes bisacodyl and the shell composition includes a film forming material and an enteric polymer. The softgel capsules further include 5 parts by weight of bisacodyl based on 100 parts by weight of the fill material. A method for producing the softgel capsule using a gel conversion is also provided.
Described are modified release softgel capsules including a pH dependent shell composition that encapsulated a controlled release fill composition, methods of preparation thereof, and methods of use thereof. The pH dependent shell composition may be characterized in that the delayed release nature of the capsules may be achieved without a separate pH dependent coating or added conventional pH dependent polymers. The softgels provide a dual controlled release platform which facilitates delivery of the active agent to a target location in the gastrointestinal tract and a controlled release profile of the active agent at said target location in the gastrointestinal tract.
A controlled release fill composition for use in soft or hard capsules, soft- or hard-shell capsules encapsulating controlled release fill compositions, a method of producing a softgel capsule with a controlled release fill composition encapsulated in the soft gel capsule shell. The controlled release fill composition includes an active pharmaceutical ingredient; polyethylene oxide having a number average molecule weight of from 0.05 M daltons to 15 M daltons; and at least one of water or a hydrophilic carrier having a number average molecule weight of from 200 daltons to 5000 daltons. Also, in the controlled release fill composition either the polyethylene oxide is present in an amount of at least 21.5 wt. %, based on a total weight of the controlled release fill composition, or the hydrophilic carrier is present in an amount up to 65 wt. %, based on a total weight of the controlled release fill composition.
The invention provides a method of generating retinal pigmented epithelial (RPE) cells from pluripotent stem cells (PSCs), and methods of use of the cells. The disclosure provides a method of generating RPE cells by differentiation of PSCs and includes the treatment of PSCs with one or more of a transforming growth factor β/SMAD2/SMAD3 pathway signaling inhibitor, a bone morphogenetic protein/SMAD1/SMAD5/SMAD8 pathway signaling inhibitor or a fibroblast growth factor/ERK pathway signaling inhibitor, and a TGFβ family protein. Use of such RPE cells include methods of treating macular degeneration by administering the RPE cells to a subject in need thereof.
The invention provides a method of generating retinal pigmented epithelial (RPE) cells from pluripotent stem cells (PSCs), and methods of use of the cells. The disclosure provides a method of generating RPE cells by differentiation of PSCs and includes the treatment of PSCs with one or more of a transforming growth factor β/SMAD2/SMAD3 pathway signaling inhibitor, a bone morphogenetic protein/SMAD1/SMAD5/SMAD8 pathway signaling inhibitor or a fibroblast growth factor/ERK pathway signaling inhibitor, and a TGFβ family protein. Use of such RPE cells include methods of treating macular degeneration by administering the RPE cells to a subject in need thereof.
The present disclosure provides activated formylglycine-generating enzymes (FGE), methods of producing activated FGE, and their use in methods of producing a protein comprising a formylglycine (FGly) residue. The methods of producing activated FGE, as well as methods of use of activated FGE in producing FGly-containing proteins, include both cell-based and cell-free methods. Compositions and kits that find use, e.g., in practicing the methods of the present disclosure are also provided.
C07K 16/00 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies
A61K 47/68 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
C07K 16/32 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products from oncogenes
Systems and methods for automated data analysis and reporting of pharmaceutical batch production records are provided. In response to receiving a user command to generate a batch report, the method can comprise automatically performing one or more statistical analyses on raw batch data extracted from one or more batch manufacturing records, generating one or more figures and one or more tables using the analyzed data, identifying one or more discussion boxes that are relevant to the analyzed data, compiling a batch report comprising the one or more identified discussion boxes, saving the batch report in a memory, and displaying the batch report on a user device.
Systems and methods for automated data analysis and reporting of pharmaceutical batch production records are provided. In response to receiving a user command to generate a batch report, the method can comprise automatically performing one or more statistical analyses on raw batch data extracted from one or more batch manufacturing records, generating one or more figures and one or more tables using the analyzed data, identifying one or more discussion boxes that are relevant to the analyzed data, compiling a batch report comprising the one or more identified discussion boxes, saving the batch report in a memory, and displaying the batch report on a user device.
Systems and methods for automated data analysis and reporting of pharmaceutical batch production records are provided. In response to receiving a user command to generate a batch report, the method can comprise automatically performing one or more statistical analyses on raw batch data extracted from one or more batch manufacturing records, generating one or more figures and one or more tables using the analyzed data, identifying one or more discussion boxes that are relevant to the analyzed data, compiling a batch report comprising the one or more identified discussion boxes, saving the batch report in a memory, and displaying the batch report on a user device.
The present disclosure provides antibody-drug conjugate (ADC) structures, which include a camptothecine or a camptothecine derivative linked to a polypeptide (e.g., an antibody) through a linker. The disclosure also encompasses compounds and methods for production of such conjugates, as well as methods of using the conjugates.
A61K 47/54 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic compound
A61K 47/64 - Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
A61K 47/68 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
C07D 491/22 - Heterocyclic compounds containing in the condensed ring system both one or more rings having oxygen atoms as the only ring hetero atoms and one or more rings having nitrogen atoms as the only ring hetero atoms, not provided for by groups , , or in which the condensed system contains four or more hetero rings
C07D 519/00 - Heterocyclic compounds containing more than one system of two or more relevant hetero rings condensed among themselves or condensed with a common carbocyclic ring system not provided for in groups or
C07K 5/062 - Dipeptides the side chain of the first amino acid being acyclic, e.g. Gly, Ala
Softgel capsules comprise a fill composition and a shell composition, wherein the fill composition includes valproic acid and the shell composition includes gelatin, a plasticizer, and an enteric polymer. The softgel capsules further include from 125 mg to 1000 mg dosing of valproic acid. A method for producing the softgel capsule using a gel mass and rotary die encapsulation is also provided.
Softgel capsules comprise a fill composition and a shell composition, wherein the fill composition includes valproic acid and the shell composition includes gelatin, a plasticizer, and an enteric polymer. The softgel capsules further include from 125 mg to 1000 mg dosing of valproic acid. A method for producing the softgel capsule using a gel mass and rotary die encapsulation is also provided.
Antibodies that include a sulfatase motif-containing tag in a constant region of an immunoglobulin (Ig) heavy chain polypeptide are disclosed. The sulfatase motif can be converted by a formylglycine-generating enzyme (FGE) to produce a formylglycine (fGly)-modified Ig heavy chain polypeptide. An fGly-modified Ig heavy chain polypeptide of the antibody can be covalently and site-specifically bound to a moiety of interest to provide an antibody conjugate. The disclosure also encompasses methods of production of such tagged Ig heavy chain polypeptides, fGly-modified Ig heavy chain polypeptides, and antibody conjugates, as well as methods of use of same.
C07K 16/30 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
A61K 47/60 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
A61K 47/68 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
Delayed release softgel capsules comprise a fill material and a pH dependent shell composition, characterized in that the delayed release nature of the capsules may be achieved without a pH dependent coating or added conventional pH dependent polymers. The delayed release softgel capsules described herein are particularly suitable for initiating release of the active agent in a target location in the colon environment.
Embodiments of the present disclosure include systems and methods for generating an executable batch record for a clinical trial study. The method includes displaying a user interface for having a production user input batch record information comprising via a production user interface (UI), and receiving packaging instructions, a bill of materials, and a lot assignment from the production user. The method further includes producing a preliminary batch record based on the information input by the production user. The method further displaying a customer UI that includes the preliminary batch record and an interface for approving the preliminary batch record, and receiving an approval of the preliminary batch record from a customer user. The method further includes producing an executable batch record for a producer to execute upon customer approval.
Disclosed in certain embodiments is a softgel capsule comprising (a) a fill material; and (b) a shell composition, wherein the fill material comprises at least 10% of a liquid medium, and wherein the shell composition comprises gelatin and a pH dependent polymer that solubilizes at a pH of less than about 6.0.
Disclosed herein are a rotary die encapsulation system and process for manufacturing capsules and uses thereof. The rotary die encapsulation system and process may be used for improving content uniformity of a multi-phase fill composition in a capsule. The rotary die encapsulation system and process may also be used for tuning dose strength of a fill composition in a capsule.
A61J 3/07 - Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
B65B 9/04 - Enclosing successive articles, or quantities of material, between opposed webs one or both webs being formed with pockets for the reception of the articles, or of the quantities of material
82.
TUMOR-ASSOCIATED CALCIUM SIGNAL TRANSDUCER 2 (TACSTD2) ANTIBODY-MAYTANSINE CONJUGATES AND METHODS OF USE THEREOF
The present disclosure provides anti-TACSTD2 (Tumor Associated Calcium Signal Transducer 2) antibody-maytansine conjugate structures. The disclosure also encompasses methods of production of such conjugates, as well as methods of using the conjugates, such as methods of treating cancer using the subject conjugates. In addition, the disclosure encompasses anti-TACSTD2 antibodies, as well as methods of making the subject anti-TACSTD2 antibodies.
A61K 31/5365 - Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and at least one oxygen as the ring hetero atoms, e.g. 1,2-oxazines ortho- or peri-condensed with heterocyclic ring systems
A61K 38/16 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof
A61K 39/39 - Medicinal preparations containing antigens or antibodies characterised by the immunostimulating additives, e.g. chemical adjuvants
A61K 47/64 - Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
A61K 47/68 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
This disclosure provides methods of using antibody-drug-conjugates of formula (I). Specifically, the disclosure provides methods of reducing target-mediated cross-reactivity by using the antibody-drug-conjugates (ADCs) of formula (I). The disclosure also includes methods of using such conjugates in a variety of therapeutic indications, as well as methods of production of such conjugates.
A61K 31/537 - Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and at least one oxygen as the ring hetero atoms, e.g. 1,2-oxazines spiro-condensed or forming part of bridged ring systems
A61K 47/64 - Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
A61K 47/68 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
C07K 16/18 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans
C07K 16/30 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
The present disclosure provides anti-TACSTD2 (Tumor Associated Calcium Signal Transducer 2) antibody-maytansine conjugate structures. The disclosure also encompasses methods of production of such conjugates, as well as methods of using the conjugates, such as methods of treating cancer using the subject conjugates. In addition, the disclosure encompasses anti-TACSTD2 antibodies, as well as methods of making the subject anti-TACSTD2 antibodies.
A61K 47/68 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
A61K 31/5365 - Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and at least one oxygen as the ring hetero atoms, e.g. 1,2-oxazines ortho- or peri-condensed with heterocyclic ring systems
A61K 38/16 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof
A61K 39/39 - Medicinal preparations containing antigens or antibodies characterised by the immunostimulating additives, e.g. chemical adjuvants
A61K 47/64 - Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
The present disclosure provides binding agents, particularly, antibodies, that comprise variable regions comprising humanized framework regions. Nucleic acids that encode one or both of the variable chains of the binding agents of the present disclosure are also provided, as are cells that include such nucleic acids. Also provided are compositions, including in some instances, pharmaceutical compositions, that include the binding agents disclosed herein. Methods of making and using the binding agents of the present disclosure are also provided. In certain aspects, provided are methods that include administering to an individual having a cell proliferative disorder a therapeutically effective amount of a binding agent disclosed herein, where the binding agent is administered to the individual to enhance an immune response, e.g., a T cell response, to abnormally proliferating cells. The binding agents are also useful in various diagnostic, and monitoring applications, which are also provided.
C07K 16/30 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
A61K 47/68 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
The present disclosure provides binding agents, particularly, antibodies, that comprise variable regions comprising humanized framework regions. Nucleic acids that encode one or both of the variable chains of the binding agents of the present disclosure are also provided, as are cells that include such nucleic acids. Also provided are compositions, including in some instances, pharmaceutical compositions, that include the binding agents disclosed herein. Methods of making and using the binding agents of the present disclosure are also provided. In certain aspects, provided are methods that include administering to an individual having a cell proliferative disorder a therapeutically effective amount of a binding agent disclosed herein, where the binding agent is administered to the individual to enhance an immune response, e.g., a T cell response, to abnormally proliferating cells. The binding agents are also useful in various diagnostic, and monitoring applications, which are also provided.
A61K 39/395 - AntibodiesImmunoglobulinsImmune serum, e.g. antilymphocytic serum
A61K 47/68 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
C07K 16/30 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
This disclosure provides methods of using antibody-drug-conjugates of formula (I). Specifically, the disclosure provides methods of reducing target-mediated cross-reactivity by using the antibody-drug-conjugates (ADCs) of formula (I). The disclosure also includes methods of using such conjugates in a variety of therapeutic indications, as well as methods of production of such conjugates.
A61K 47/68 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
A61K 31/537 - Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and at least one oxygen as the ring hetero atoms, e.g. 1,2-oxazines spiro-condensed or forming part of bridged ring systems
A61K 47/64 - Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
C07K 16/18 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans
C07K 16/30 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
The present disclosure provides anti-CD37 antibody-maytansine conjugate structures. The disclosure also encompasses methods of production of such conjugates, as well as methods of using the same.
A61K 47/68 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
89.
ANTIBODIES AND ANTIBODY CONJUGATES SPECIFIC FOR NECTIN-4 AND METHODS OF USE THEREOF
The present disclosure provides antibodies specific for Nectin-4 and antibody conjugates e.g., antibody-drug conjugates (ADCs), comprising such antibodies. The disclosure also encompasses methods of production of such antibodies and antibody conjugates, as well as methods of using the same. Also provided are compositions that include the antibodies and antibody conjugates of the present disclosure, including in some instances, pharmaceutical compositions. In certain aspects, provided are methods of using the ADC that include administering to an individual having a cell proliferative disorder a therapeutically effective amount of the antibodies or antibody conjugates of the present disclosure.
A61K 31/706 - Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom
A61K 47/54 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic compound
A61K 47/68 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
90.
ANTIBODIES AND ANTIBODY CONJUGATES SPECIFIC FOR NECTIN-4 AND METHODS OF USE THEREOF
The present disclosure provides antibodies specific for Nectin-4 and antibody conjugates e.g., antibody-drug conjugates (ADCs), comprising such antibodies. The disclosure also encompasses methods of production of such antibodies and antibody conjugates, as well as methods of using the same. Also provided are compositions that include the antibodies and antibody conjugates of the present disclosure, including in some instances, pharmaceutical compositions. In certain aspects, provided are methods of using the ADC that include administering to an individual having a cell proliferative disorder a therapeutically effective amount of the antibodies or antibody conjugates of the present disclosure.
A61K 47/54 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic compound
A61K 47/68 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
91.
ANTIBODY-DRUG CONJUGATES AND METHODS OF USE THEREOF
The present disclosure provides antibody conjugates (e.g., antibody-drug conjugates (ADCs)). The disclosure also encompasses methods of production of such conjugates, as well as methods of using the same. Also provided are compositions that include the ADC of the present disclosure, including in some instances, pharmaceutical compositions. In certain aspects, provided are methods of using the ADC that include administering to an individual a therapeutically effective amount of the ADC of the present disclosure.
A61K 31/437 - Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a five-membered ring having nitrogen as a ring hetero atom, e.g. indolizine, beta-carboline
The present disclosure provides antibody conjugates (e.g., antibody-drug conjugates (ADCs)). The disclosure also encompasses methods of production of such conjugates, as well as methods of using the same. Also provided are compositions that include the ADC of the present disclosure, including in some instances, pharmaceutical compositions. In certain aspects, provided are methods of using the ADC that include administering to an individual a therapeutically effective amount of the ADC of the present disclosure.
A61K 31/437 - Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a five-membered ring having nitrogen as a ring hetero atom, e.g. indolizine, beta-carboline
C07D 487/12 - Heterocyclic compounds containing nitrogen atoms as the only ring hetero atoms in the condensed system, not provided for by groups in which the condensed system contains three hetero rings
94.
ANTIBODY CONJUGATES SPECIFIC FOR MUCIN-1 AND METHODS OF USE THEREOF
The present disclosure provides antibody conjugates (e.g., antibody-drug conjugates (ADCs)) specific for MUC1. The disclosure also encompasses methods of production of such conjugates, as well as methods of using the same. Also provided are compositions that include the ADC of the present disclosure, including in some instances, pharmaceutical compositions. In certain aspects, provided are methods of using the ADC that include administering to an individual having a cell proliferative disorder a therapeutically effective amount of the ADC of the present disclosure.
C07D 487/12 - Heterocyclic compounds containing nitrogen atoms as the only ring hetero atoms in the condensed system, not provided for by groups in which the condensed system contains three hetero rings
A61K 31/5025 - PyridazinesHydrogenated pyridazines ortho- or peri-condensed with heterocyclic ring systems
A softgel capsule is provided which can be used with a fill composition including a high alcohol content. The softgel capsule includes a shell composition including a film forming polymer and a plasticizer. The fill composition includes at least about 20 wt. % alcohol. The softgel capsule has a weight loss change of less than about 10% after 30 days, 90 days, 6 months, 9 months or 12 months storage at ambient conditions.
A23L 29/269 - Foods or foodstuffs containing additivesPreparation or treatment thereof containing gelling or thickening agents of microbial origin, e.g. xanthan or dextran
A softgel capsule is provided which can be used with a fill composition including a high alcohol content. The softgel capsule includes a shell composition including a film forming polymer and a plasticizer. The fill composition includes at least about 20 wt. % alcohol. The softgel capsule has a weight loss change of less than about 10% after 30 days, 90 days, 6 months, 9 months or 12 months storage at ambient conditions.
A23L 29/269 - Foods or foodstuffs containing additivesPreparation or treatment thereof containing gelling or thickening agents of microbial origin, e.g. xanthan or dextran
A23P 10/30 - Encapsulation of particles, e.g. foodstuff additives
A61K 9/00 - Medicinal preparations characterised by special physical form
Provided are humidity control devices, systems, and methods of controlling humidity in an enclosed container. A humidity control device can comprise a cap configured to attach to a container; a first tubular member passing through the cap to form a first portion of the first tubular member and a second portion of the first tubular member, the first portion comprising a proximal end extending away from the cap and the second portion comprising an inlet configured to receive a fluid, wherein when the cap is attached to the container, the first portion is within the container and the second portion is outside of the container, wherein the proximal end of the first tubular member comprises an outlet for delivering the fluid to an interior space of the container.
F26B 3/08 - Drying solid materials or objects by processes involving the application of heat by convection, i.e. heat being conveyed from a heat source to the materials or objects to be dried by a gas or vapour, e.g. air the gas or vapour flowing through the materials or objects to be dried so as to loosen them, e.g. to form a fluidised bed
F26B 21/00 - Arrangements for supplying or controlling air or gases for drying solid materials or objects
Provided are humidity control devices, systems, and methods of controlling humidity in an enclosed container. A humidity control device can comprise a cap configured to attach to a container; a first tubular member passing through the cap to form a first portion of the first tubular member and a second portion of the first tubular member, the first portion comprising a proximal end extending away from the cap and the second portion comprising an inlet configured to receive a fluid, wherein when the cap is attached to the container, the first portion is within the container and the second portion is outside of the container, wherein the proximal end of the first tubular member comprises an outlet for delivering the fluid to an interior space of the container.
F26B 3/08 - Drying solid materials or objects by processes involving the application of heat by convection, i.e. heat being conveyed from a heat source to the materials or objects to be dried by a gas or vapour, e.g. air the gas or vapour flowing through the materials or objects to be dried so as to loosen them, e.g. to form a fluidised bed
F26B 21/00 - Arrangements for supplying or controlling air or gases for drying solid materials or objects
Disclosed in certain embodiments is a delayed release softgel capsules comprise a fill material that is encapsulated in a pH dependent shell composition, the pH dependent shell composition including pectin and gellan gum. Also disclosed are methods of preparing any of the delayed release softgel capsules described herein and methods of use thereof.
A23L 29/269 - Foods or foodstuffs containing additivesPreparation or treatment thereof containing gelling or thickening agents of microbial origin, e.g. xanthan or dextran
Provided are pharmaceutical compositions and methods for preparing pharmaceutical compositions comprising wax coated tablets. Specifically, a wax coating can be applied to a pharmaceutical tablet prior to the film coating process.
