The present invention provides methods for quantitating one or more biomolecuies in a sample using IR. based techniques, sample holder devices for use la such methods as well as methods lor manufacturing such sample holder devices.
G01N 21/35 - Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using infrared light
G01N 33/483 - Physical analysis of biological material
G01N 1/36 - Embedding or analogous mounting of samples
2.
METHODS FOR PURIFYING A TARGET PROTEIN FROM ONE OR MORE IMPURITIES IN A SAMPLE
The present invention relates, at least in part, to improved methods of protein purification. In particular, the present invention relates, at least in part, to methods for purifying an Fc region containing protein from a composition comprising the Fc region containing protein and one or more impurities, where the methods eliminate the need for a holding tank and/or a buffer exchange step.
A feed bag construction is provided comprising a feed bag, a first conduit sealed to the feed bag, a second conduit sealed to the interior of the feed bag for supplying wash reagent to the feed bag and a one piece cap that is removably mounted on the first conduit. The first conduit is provided with a hand operated butterfly valve to open or close the conduit.
B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glasswareDroppers
A61J 1/05 - Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids
B65D 75/58 - Opening or contents-removing devices added or incorporated during package manufacture
4.
MODIFIED PHOTOPROTEINS WITH INCREASED AFFINITY FOR CALCIUM AND ENHANCED BIOLUMINESCENCE AND USES THEREOF
The present invention provides modified photoproteins, e.g., modified Clytin, having an increased affinity for calcium as well as an enhanced bioluminescence and their use as calcium indicators in reporter gene systems and in cell-based assays.
C07K 14/435 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from animalsPeptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from humans
5.
LARGE AREA SCANNING APPARATUS FOR ANALYTE QUANTIFICATION BY SURFACE ENHANCED RAMAN SPECTROSCOPY
Raman spectra of protein immunoblots or enzyme linked immunosorbant assay procedures are acquired with a scanning Raman spectrometer. The sensitivity of the measurement is increased by conjugating secondary antibodies used in the Western blot and ELISA methods to surface enhanced Raman Scattering (SERS) labels. The resulting blot or well plate is analyzed with a Raman system that has forms a pixel map of the sample. More specifically, the Raman system generates an effectively line-shaped illumination pattern and scans the sample in the direction perpendicular to the line while the signal is accumulating on the detector. Each pixel is therefore a rectangle defined by the length of the illumination and the distance traveled by the sample within the duration of signal accumulation on the detector. The pixels are sequentially acquired to generate a map of the sample.
A method for determining mixing time for a variety of vessels is disclosed. This method utilizes information about the configuration, such as vessel diameter, impeller diameter and speed, fluid density and viscosity, and fluid height to determine the appropriate mixing time. In another embodiment, the parameters used to create small batches of material can be used to scale up to larger vessel sizes.
A connector (10) is provided for connecting a flexible conduit (22) with a second conduit (30) having a barbed outer surface. The connector (10) accommodates the end of the flexible conduit (22) and the end of the second conduit (30) in a manner which prevents removal of the flexible conduit (22) and the second conduit (30) from the connector (10). Optionally, the connector (10) has a ring (79) that may be used to apply additional pressure and security to the outer surface of the flexible conduit, additionally, the connector may have a wireless enabled communication (100) and optionally, memory device such as a RFID tag attached or affixed to it.
F16L 33/22 - Arrangements for connecting hoses to rigid membersRigid hose-connectors, i.e. single members engaging both hoses with means not mentioned in the preceding groups for gripping the hose between inner and outer parts
F16L 37/098 - Couplings of the quick-acting type in which the connection between abutting or axially-overlapping ends is maintained by locking members combined with automatic locking by means of flexible hooks
8.
REMOVAL OF MICROORGANISMS FROM FLUID SAMPLES USING NANOFIBER FILTRATION MEDIA
A method for removing microorganisms from liquid samples and a nanofiber containing liquid filtration medium that simultaneously exhibits high liquid permeability and high microorganism retention. Microorganisms such as bacteria, particularly B. Diminuta, are removed from a liquid by passing the liquid through a porous nanofiber containing filtration medium having a B. Diminuta LRV greater than about 9, and the nanofiber(s) has a diameter from about 10 nm to about 1,000 nm. Another method for removing microorganisms such as bacteria and Mycloplasma, includes passing the liquid through a porous nanofiber containing filtration medium having a microorganism LRV greater than about 8, and the nanofiber(s) has a diameter from about 10 nm to about 1,000 nm. The filtration medium can be in the form of a fibrous electrospun polymeric nanofiber liquid filtration medium mat.
A61L 2/02 - Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lensesAccessories therefor using physical phenomena
A61L 2/00 - Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lensesAccessories therefor
B01D 39/16 - Other self-supporting filtering material of organic material, e.g. synthetic fibres
9.
DEVICE FOR DETERMINATING A PHYSICAL VALUE OF A LIQUID FLOWING IN A PIPE
A device for determining a physical value of a liquid flowing in a pipe, without contact with said liquid, said device comprising: - a sensor (3) for said physical value; - a connector (2) to insert into said pipe and comprising: - an internal passage (13) extending between two apertures (11, 12), - a flexible membrane (6) for a pressure sensor, forming a wall of said internal passage (13); and - means (27, 62) for fastening said sensor (3) onto said connector (2); characterized in that said sensor is a temperature sensor (3) fastened to said connector (2) with the sensitive part of said sensor (3) turned towards said membrane (6).
G01L 19/00 - Details of, or accessories for, apparatus for measuring steady or quasi-steady pressure of a fluent medium insofar as such details or accessories are not special to particular types of pressure gauges
10.
HEMODIALYSIS AND PERITONEAL DIALYSIS SYSTEMS HAVING ELECTRODEIONIZATION CAPABILITIES
Systems and methods for hemodialysis or peritoneal dialysis having integrated electrodeionization capabilities are provided. In an embodiment, the dialysis system (10) includes a carbon source (40), a urease source (50) and an electrodeionization unit (30). The carbon source (40) and urease source (50) can be in the form of removable cartridges.
A negatively charged microporous filtration medium having a high charge density comprising a porous substrate and a polymerized cross-linked polymeric coating located on the inner and outer surfaces of the substrate. The coating may be formed from a reactant solution comprising negatively charged cross-linkable polymerizeable acrylamidoalkyl monomers and acrylamido cross-linking agents which are polymerized in situ on the substrate. The negatively charged microporous filtration medium are suitable for use as prefiltration membranes for selectively removing protein aggregates from a protein solution.
A device for supporting a plurality of flexible containers (1) for liquid; characterized in that it comprises a plurality of baskets (10), each adapted to contain at least one said flexible container (1), a magazine (60) to receive said baskets (10), able to adopt an operating configuration in which said baskets (10) are disposed inclined one above the other, which magazine (60) comprises support means (75) for said baskets (10), able to adopt a loading/unloading position in which they are adapted such that each said basket (10) can be loaded/unloaded along a horizontal path, and able to adopt an operating position in which they are adapted to maintain each said basket (10) in inclined position to make said magazine (60) adopt said operating configuration, and means (83) for driving said support means (75) between said loading/unloading position and said operating position.
A47F 5/00 - Show stands, hangers, or shelves characterised by their constructional features
A47B 57/04 - Cabinets, racks or shelf units, characterised by features for adjusting shelves or partitions with means for adjusting the inclination of the shelves
13.
METHOD FOR PROVIDING A CIRCUIT FOR BIOLOGICAL LIQUID AND CIRCUIT OBTAINED
The method comprises the step of forming pipes (12) by clamping a bag between shells (13, 14) and by injecting an inflating agent via an inflating connector. The circuit comprises a bag (126) and a press (10) comprising two shells (13, 14) clamping said bag in a state in which pipes (12) are formed between the films (25, 26) of the bag.
The biocontainer of the present invention provides a low cost, simple solution of many of the problems encountered during shipping, freezing and thawing of biopharmaceutical materials. The present invention enables a user to monitor the temperature profile of each biopharmaceutical container during the cryogenic process, so as to ensure the integrity of materials within each biocontainer by using a pre-installed and pre-sterilized temperature sensor. In some embodiments, the sensor assembly includes a wireless transmitter and is capable of transmitting information regarding the measured reading. In other embodiments, the sensor assembly includes a processing unit, which determines whether the temperature profile is acceptable. In a further embodiment, an indicator is included, such that the processing unit may indicate whether the biopharmaceutical material has been properly frozen. In other embodiments, the sensor assembly also includes a storage element, which is capable of storing various parameters during the freezing process.
Container for sample preparation or processing, such as biomass culturing or processing, and optionally sample purification. In certain embodiments, the reactor is a bioreactor that includes a stirred cell device that simulates a tangential flow filter to reduce or eliminate clogging that can be caused by the solids generated. In certain embodiments, the solids comprise a precipitate or floc or beads, such as one that includes a polymer that binds the biomolecule(s) of interest, and impurities. In its method aspects, embodiments disclosed herein include purification and isolation of biomolecules of interest derived from cell culture fluids. The methods include carrying out sample preparation or processing in a container, culturing a biomass; generating solids by precipitating or flocculating a biomolecule of interest from the cultured broth; preventing the solids from settling in the container by agitation; and purification, such as by eluting the biomolecule of interest and filtering the same.
The present invention relates to a bimodal polymer such as a soluble polymer capable of irreversibly binding to insoluble particulates and a subset of soluble impurities and also capable of reversibly binding to one or more desired biomolecules in an unclarified biological material containing stream and the methods of using such a material to purify one or more desired biomolecules from such a stream without the need for prior clarification. Such a polymer comprises domains of charged pendant groups such as primary, secondary, tertiary or quaternary amines, (first mode) and is rendered insoluble and precipitates out of solution simply upon complexing with oppositely charged solid particulates and a fraction of the soluble impurities in an amount sufficient to form an aggregate that can no longer be held in solution. The polymer further comprises other domains of pendant groups that are charged or uncharged, hydrophilic or hydrophobic or have a ligand that is selective for the biomolecule of interest depending on the process conditions such as pH, ionic strength, salts, and the like (second mode). When present in one mode, such as the uncharged form, said pendant groups are capable of binding to one or more desired biomolecules within the stream (protein, polypeptide, etc) in an unclarified cell broth. The precipitate can then be removed from the stream, such as by being filtered out from the remainder of the stream and the desired biomolecule is recovered such as by selective elution.
The invention relates to a resealable or a single use cell culture assembly for use in growing, storing and transporting, cell and tissue cultures. The assembly includes a support frame for receiving a base member insert having an upper surface, such as a microscope slide, and a well frame, preferably partitioned into a plurality of well compartments having sidewalls with upper and lower surfaces, upper and lower edges, and upper and lower well openings. The well frame is adapted to be operatively positioned on the upper surface of the base member, and includes a sealing means positioned on or within the lower edge of the well frame. The sealing means is adapted to operatively create a liquid-impermeable releasable seal or barrier when the lower surface of the well frame is positioned on the upper surface of the base member, such that the sealing means is releasably positioned on the upper surface of the base member for maintaining a liquid-impermeable barrier between well compartments. The assembly may include a cover or lid positioned over the upper opening of the well frame. When the assembly is in a closed position, the well frame can be secured to the support frame by a variety of closure means.
The present invention provides methods of quantifying protein leakage from a protein based affinity chromatography media (e.g., protein A, protein G and protein L based affinity chromatography media), where such a protein is used for isolating and/or removing a molecule which binds the protein (e.g., an immunoglobulin).
The present invention is a cell cultivating vessel or device, such as a single or multitier flask, including a cover having a top plate, a side wall and a resealable port; an intermediate tray for receiving cells and cell culture media, having a bottom plate, a side wall, and a gap region formed between an interior upwardly angled lip located on an interior portion of the intermediate tray bottom plate and an adjacent outwardly angled side wall portion of the intermediate tray bottom plate, wherein the lip has a outwardly swooping curvilinear edge feature; and a base tray for receiving the cells and cell culture media, including a bottom plate and a side wall. The intermediate tray is positioned between the cover and the base tray, such that the gap region of the intermediate tray bottom plate is in alignment with the port located on the cover, resulting in the port, the intermediate tray and the base tray in fluid communication with one another which provides direct access, such as by a user to remove and/or add cells, cell media, and nutrients located on each of the intermediate and/or the base trays. Alternatively, the cell cultivating flask includes a plurality of intermediate trays stacked on top of one another and the gap regions of each intermediate tray are in alignment with each other and with the port on the cover.
A system and method for implementing embedded electronics in environments where radiation or extreme temperatures are used is disclosed. Embedded electronics are affixed to various components of a pharmaceutical system, thereby enabling the customer to download pertinent information about the component, such as lot number, date of manufacturer, test parameters, etc. Additionally, these electronics allow an array of functions and features to be implemented, such as integrity tests and diagnostics. The electronics in the pharmaceutical components utilize a technology that is not as susceptible to radiation and extreme temperatures as traditional electronics.
The invention relates to asymmetric porous exiting membranes having a plurality of unbound size-exclusion and/or affinity-exclusion particles retained within the membrane pores, for the separation and retention of analytes of interest contained in a liquid sample, by size-exclusion and/or affinity binding, as the sample flows through the membrane. The size- exclusion and affinity binding properties of the porous membrane can be tuned or adjusted by controlling the shape and/or size and/or affinity of the particles retained within the membrane pores. Devices, kits and methods of using and making porous asymmetrical membranes having a plurality of unbound size- exclusion and/or affinity-exclusion particles within the membrane pores are also provided.
B01D 65/08 - Prevention of membrane fouling or of concentration polarisation
B01D 69/02 - Semi-permeable membranes for separation processes or apparatus characterised by their form, structure or propertiesManufacturing processes specially adapted therefor characterised by their properties
The invention relates to asymmetric porous exiting membranes having a plurality of unbound size-exclusion particles retained within the membrane pores, for the separation and retention of analytes of interest, contained in a liquid sample, by size-exclusion, as the sample flows through the membrane. The size-exclusion properties of the porous membrane can be tuned or adjusted by controlling the shape and/or size of the unbound size-exclusion particles retained within the membrane pores. Devices, kits and methods of using and making porous asymmetrical membranes having a plurality of unbound size-exclusion particles within the membrane pores are also provided.
B01D 69/02 - Semi-permeable membranes for separation processes or apparatus characterised by their form, structure or propertiesManufacturing processes specially adapted therefor characterised by their properties
The present invention is a disposable bioreactor formed of molded plastic. The bioreactor (2) is presterilized and has a top (16) and body (22) sealed to each other. One or more ports (30a-c, 32a-c) are formed in the top and side of the housing Preferably at least one port is below the liquid/air level for the housing. The one or more ports that are below the liquid/air interface level may be used as sampling ports or access ports for probes or drains or supply ports for liquids or gases. The bioreactor provides a direct retrofit for the existing glass or steel assembly that utilizes the existing support structures and controls. The molded design overcomes issues of discontinuity, dead spots and the like due to its fixed dimensions that are built in by the molding process. Reproducable probe and other equipment location is also guaranteed through the use of the molded port features. The molded plastic allows for greater flexibility in material selection to reduce or eliminate lipid or cholesterol binding.
A disposable container for fluid is provided. The container has a vortex breaker positioned adjacent the container outlet and a fluid diverter positioned adjacent each inlet to the container.
This is a method for analyzing the purity of water at the outlet from a purification device. It comprises the following steps: a) sending the liquid at the outlet from the filter means (1) to a resistivity measuring cell (4) to determine its resistivity PUPW; b) establishing a reference mode by exposing a portion of the liquid to said oxidation means (2) during a given number of significantly different time periods; c) determining by regression the resistivity at infinity p∞REF of said liquid in this reference mode; d) establishing an analysis mode by causing said liquid to be analyzed to pass through the resistivity measuring cell (4); e) determining the resistivity at infinity p∞ of said liquid in this analysis mode by successive iterations; and f) calculating the quantity of organic compounds contained in said purified liquid from this resistivity at infinity p∞ and at least the values PUPW and P∞REF.
G01N 27/06 - Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating impedance by investigating resistance of a liquid
A disposable container for fluid having an inlet and an outlet is provided. The container has a vortex breaker having a solid surface adapted to initially direct fluid away from the outlet and then through the outlet positioned adjacent the container outlet.
ARIZONA BOARD OF REGENTS FOR AND ON BEHALF OF ARIZONA STATE UNIVERSITY (USA)
MILLIPORE CORPORATION (USA)
Inventor
Dimitrakopoulos, Aristotelis
Wang, Joseph
Mabic, Stéphane
Glipa, Céline
Rajagopalan, Pascal
Abstract
Among others, techniques and systems are disclosed for detecting trace levels of heavy metal ions in a sample liquid. A voltage is applied to a sample liquid that includes metal complexes. A current signal associated with the metal complexes is measured. The measured current signal is processed to simultaneously detect a presence of two or more metal ions associated with the metal complexes.
G01N 27/26 - Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variablesInvestigating or analysing materials by the use of electric, electrochemical, or magnetic means by using electrolysis or electrophoresis
A method and apparatus for providing wireless communication and optionally power to the interior of a housing assembly is disclosed. In one embodiment, an antenna is molded within a gasket material, such as silicon, so as to be completely encapsulated. The gasket preferably includes at least one support arm, which holds the antenna toward the middle of the housing, so as to minimize interference from the metal housing. In further embodiments, an inductive coil is encapsulated in the gasket. An alternating current is passed through this coil to create a changing magnetic field, which can then be used to create electrical power in physically separate components, such as filtering elements. In certain embodiments, multiple loops are molded to correspond to multiple filtering elements within the housing.
A system and method for interfacing non-sterile sensors to a sterile flow stream is disclosed. Typically, sensors cannot be sterilized in the same manner as other components of the flow stream. This results in complex processes to incorporate a sterilized sensor into a sterilized flow stream. By introducing a separation membrane, the desired sensor can be interfaced to the sterile flow stream. By doing so, the sensor need not be sterile, only sufficiently clean. The membrane separates the sterile environment within the flow stream from the sensor, while still permitting the sensor to function.
A method and apparatus for providing more reliable wireless communication and power to sensors in electrically challenging bioprocess environments is disclosed. An unconnected antenna is located within the bioprocess environment, preferably in the same plane as the primary powered antenna. This unconnected antenna, also referred to as reflective antenna, enhances and confines the electromagnetic field created by the powered antenna. This reflective antenna is incorporated in or proximate to the devices containing a sensor or communication device. In one embodiment, the reflective antenna is incorporated into the filter housing. In another embodiment, it is incorporated into the filtering element itself. In another embodiment, it is incorporated into or affixed on the disposable bioprocess components, such as bags and tubes.
A tie wrap connector (10) is formed of a strap (12), a locking head (14) and an insert (16) positioned adjacent said locking head (14). The insert (16) has an arc shaped surface (18) positioned remote from the locking head (14). The strap (12) is positioned around a device to be secured to the locking head (14). The insert (16) is adjacent the locking head (14) and the device to be secured and is drawn against the outer surface of the device to be secured by the strap (12) as it is secured to the locking head (14).
F16L 3/137 - Supports for pipes, cables or protective tubing, e.g. hangers, holders, clamps, cleats, clips, brackets substantially surrounding the pipe, cable or protective tubing comprising a member substantially surrounding the pipe, cable or protective tubing and consisting of a flexible band
F16L 33/035 - Hose-clips fixed by means of teeth or hooks
B65D 63/10 - Non-metallic straps, tapes, or bandsFilamentary elements, e.g. strings, threads or wiresJoints between ends thereof
A filtration apparatus is provided comprising a housing having an inlet (14) and an outlet (16) and a plurality of spirally wound filtration cartridges (18,24). The filtration cartridges include two filter layers, a feed spacer layer and a permeate spacer layer. Seals are provided to prevent admixtures of feed and permeate and to permit recovery of permeate in a dead-end filtration mode.
The invention relates to a method for the extraction and detection of nucleic acids on a membrane, making it possible to identify the microorganisms present in low concentration in a liquid or gaseous medium, as well as a novel lysis composition comprising guanidium chloride and between 0.1 and 1% N-Lauroyl-Sarcosine (NLS) making it possible to implement this method.
The present invention relates to a selectively soluble polymer capable of binding to a desired molecules in an unclarified mixture containing various biological materials and the methods of using such a polymer to purify a molecule from such a mixture. The polymer is soluble in the mixture under a certain set of process conditions such as pH or temperature and/or salt concentration and is rendered insoluble and precipitates out of solution upon a change in the process conditions. The polymer is capable of binding to the desired molecule (protein, polypeptide, etc) and remains capable of binding to that molecule even after the polymer is precipitated out of solution. The precipitate can then be filtered out from the remainder of the stream and the desired biomolecule is recovered such as by elution and further processed.
The verification and control method for at least one water purification system comprises: - a step of supplying, by a server embedded with said water purification system, an editing interface comprising a zone for selecting items of exploitation information representing physical quantities associated with the water purification system, - a step of selecting, via said first remote browser, at least one said item of exploitation information to constitute at least one exploitation interface page, - a step of sending a request to access a said exploitation page, by said second remote browser, to said server, - a step of collecting the value of each physical quantity represented by a selected item of information to constitute said page, and - a step of supplying, by said server, said page comprising each said collected value.
A filtration cartridge is provided comprising one or a stack of filtration units (26) sealed to each other at their outer periphery and to end caps (22, 24) thereby eliminating the need for a housing surrounding the stack. Each unit (26) comprises two support plates (42) bonded together and each having an outer membrane (38) and an inner membrane (40), the outer having a larger surface area than the inner. Fluid pathways are provided so that filtration of all incoming feed is assured prior to passing from the cartridge as filtrate. Two permeate pathways are provided to direct permeate to an outlet from the filtration cartridge. Further, a vent passage (56,27) is foressen.
The present invention provides a vacuum filter device (10) which includes a filter body (11) having two holders (12, 13) on opposite sides of a filter. Each holder contains a closed container (15, 16) in a fluid-tight, sealed relationship.The filter is retained by a compression sealing element that resiliently applies a sealing pressure to the upper surface of the filter. The sealing element is maintained in place by a compression element formed of a ring that applies a desired compressive force to the sealing element. The compression element is bonded to a portion of the body to hold it, the sealing element and filter in place and under a compression seal. Other aspects of the invention include provisions for forming a port in the compression element that can be aligned with the vent of the device. The invention also can provide for an alignment feature on the compression element that ensures the port is in alignment with the vent of the device. The device also includes a vacuum port (26) communicating with the downstream side of the filter, and hence the filtrate container.
B01D 29/05 - Filters with filtering elements stationary during filtration, e.g. pressure or suction filters, not covered by groups Filtering elements therefor with flat filtering elements supported
A filtration cartridge (20) is provided comprising one or a stack of filtration units (26) sealed to each other at their inner periphery and to end caps (22, 24) eliminating the need for a housing surrounding the stack. Fluid pathways are provided so that filtration of all incoming feed is assured prior to passing from the cartridge as filtrate. The filtration cartridge can be provided with a single outlet (30).
Filtration device suited for concentration of liquid samples, particularly biomolecules, and a method of concentrating, desalting, purifying and/or fractionating liquid samples. In certain embodiments the device includes a housing having a sample reservoir, and two substantially vertically oriented and spaced apart membranes disposed in the housing. An underdrain is associated with each membrane such that fluid passing through each membrane flows through a respective underdrain into a filtrate collection chamber. The fluid that does not pass through the membrane is collected in the retentate collection chamber, and can be recovered such as by a reverse spinning step, achieving recoveries greater than about 90%. The substantially vertical orientation of the membranes increases the available membrane area by at least 2.7 times the area available in a conventional filter device. The two-panel configuration also maintains more available membrane area in use during the last stages of filtration than a one-panel configuration.
A method for retention testing sterilizing grade filters comprises: a) providing a stock of Acholeplasma laidlawii; b) growing up the stock of A. laidlawii for about 24 hours or less in a single serum-free growth medium that supports cell growth to a high titer and yields a cellular morphology where the cells are small, deaggregated and spherical, thereby producing a bacterial culture; c) challenging a test filter by filtering the bacterial culture through the test filter at a known challenge level, thereby producing a filtrate downstream of the test filter; and d) detecting concentration of A. laidlawii in the filtrate. Serum-free growth media for cultivating or storing A. laidlawii are also described.
Liquid chromatography-mass spectrometry to verify the presence or absence of the extractables introduced into a biopharmaceutical product during manufacture, filtration or storage at above a certain concentration. The method disclosed herein can be used to detect the presence of extractables in the actual biopharmaceutical product rather than a surrogate solvent system. Detection of the extractables in the actual drug product provides an accurate description of the leachables profile likely to be introduced to the human or animal patient. In one embodiment, the extractable are introduced by filtration of the biopharmaceutical product.
In accordance with an embodiment of the invention, there is provided a method for reducing or eliminating matrix interfering components in a biopharmaceutical product in a liquid chromatography-mass spectrometry system. The method comprises diverting to waste the entire flow of an eluant emerging from liquid chromatography of a sample, for a time period to remove contaminants that cause matrix interference to a degree sufficient to allow a desired accuracy in detection of an extractable; and, after the time period, directing the entire flow of the eluant to a mass spectrometer to detect the presence of the extractable.
G01N 30/84 - Preparation of the fraction to be distributed
H01J 49/04 - Arrangements for introducing or extracting samples to be analysed, e.g. vacuum locksArrangements for external adjustment of electron- or ion-optical components
The present invention uses a wireless memory/communication device at least on the one or more sample storage devices, preferably on both the one or more sample storage devices and the sampling holder, optionally the port on the equipment as well. Data such as that relating to the vessel, the location of the port on the vessel, the device, its manufacture date or lot number, the date of the installation, sterilization and/or taking of a sample along with the person who installed the device and/or took the sample can be read and preferably added to the wireless device when a read/write type of device as these events occur through a scanner/reader/writer device (fixed or hand held). The sample storage device in the laboratory can also then be read and recorded to track the sample storage device's life.
A system and apparatus (10) is provided for processing fluid reagents (12, 14, 16, 18) comprising disposable fluid conduits and a reusable conduit support system (20). The fluid conduits are connected to at least one source of fluid and to at least one unit operation (22) such as filtration.
ARIZONA BOARD OF REGENTS, ACTING FOR AND ON BEHALF OF ARIZONA STATE UNIVERSITY (USA)
MILLIPORE CORPORATION (USA)
Inventor
Wang, Joseph
Dimitrakopoulos, Aristotelis
Le Ninivin, Celine
Mabic, Stéphane
Abstract
A systems and apparatus for measuring non-electroactive materials in liquids using electrochemical detection. A first electrical activity of a electroactive material is detected in absence of a target non-electroactive material (Step 120). A second electrical activity of the electroactive material is detected in presence of the target non-electroactive material (Step 130). A difference between the first and second electrical activities is obtained, and based on the obtained difference, a concentration of the target non-electroactive material is identified (Step 140).
G01N 27/42 - Measuring deposition or liberation of materials from an electrolyteCoulometry, i.e. measuring coulomb-equivalent of material in an electrolyte
A polymeric composition resistant to degradation by exposure to gamma radiation comprising PVDF and between 1 and 20% by weight HDPE based on the total weight of the polymeric composition.
The invention relates to cell culture methods, kits and cell lines for producing recombinant products, e.g. therapeutic proteins and antibodies, in the presence of reduced levels of one or more contaminants and further to methods of purifying those products.
The present invention relates to methods, cell lines and kits for producing high titers of recombinant proteins without the need for gene amplification.
The present invention relates to a selectively soluble polymer capable of binding to one or more constituents in a mixture containing various biological materials and the methods of using such a polymer to purify a biomolecule from such a mixture. The polymer is soluble in the mixture under a certain set of process conditions such as pH or temperature and is rendered insoluble and precipitates out of solution upon a change in the process conditions. While in its solubilized state, the polymer is capable of binding to a selected entity within the stream such as impurities (DNA, RNA, host cell protein, endotoxins, etc) in a cell broth and remains capable of binding to that entity even after the polymer is precipitated out of solution. The precipitate can then be filtered out from the remainder of the stream and the desired biomolecule is recovered and further processed.
The present invention relates to a selectively soluble polymer capable of binding to a desired biomolecules in a mixture containing various biological materials and the methods of using such a polymer to purify a biomolecule from such a mixture. The polymer is soluble in the mixture under a certain set of process conditions such as pH or temperature and/or salt concentration and is rendered insoluble and precipitates out of solution upon a change in the process conditions. The polymer is capable of binding to the desired biomolecule (protein, polypeptide, etc) and remains capable of binding to that biomolecule even after the polymer is precipitated out of solution. The precipitate can then be filtered out from the remainder of the stream and the desired biomolecule is recovered such as by elution and further processed.
The invention is to a method for purifying proteins using a bed of 'cored beads' in a flow-through or polishing chromatography mode. Using a pellicular agarose/non-porous 'cored bead' media provides one with media that have much improved permeability and mechanical properties over existing beads, while maintaining an increased protein 'safety factor' and ease of scale-up over existing membrane devices. Cored agarose media use rigid internal beads (in this case beads of non-porous, synthetic polymer, metal or glass) which form incompressible and highly permeable packed beds especially when the agarose coating is relatively thin (e.g.5-15 microns on a greater than 50 micron diameter core). This enhanced permeability results in a lower protein capacity (especially in terms of g protein/ liter of media). Therefore, these materials can be used in applications where highly permeable beds are desired because one can tune the capacity, permeability and bed rigidity to maximize throughput or minimize processing time.
B01D 15/36 - Selective adsorption, e.g. chromatography characterised by the separation mechanism involving ionic interaction, e.g. ion-exchange, ion-pair, ion-suppression or ion-exclusion
G01N 30/96 - Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography using ion-exchange
B01J 20/286 - Phases chemically bonded to a substrate, e.g. to silica or to polymers
