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STERILITY TESTING
Sterility testing of unprocessed and final bulk, final vials, prebanking cells, and cell and virus banks is typically performed by directly inoculating the test article into 2 different types of media that support the growth of aerobic and anaerobic bacteria, respectively. Test articles areHOME | BIORELIANCE
Biomanufacturing Services. BioReliance is dedicated to meeting your manufacturing needs for the production of cell banks, viral seed stocks, and viral vaccines. At BioReliance, we specialize HOME | BIORELIANCETRANSLATE THIS PAGE バイオ受託製造サービス. BioReliance is dedicated to meeting your manufacturing needs for the production of cell banks, viral seed stocks, and viral vaccines. At BioReliance, we specialize VIRUS BANK MANUFACTURING The Virus Bank (Virus Seed, Virus Stock) is a vital part of manufacturing a biological product. The creation of a Master Virus Bank ensures reproducible testing and production of recombinant viruses for the production of vaccines and recombinant proteins. CELL LINE AUTHENTICATION Cell Line Authentication. We offer a variety of services in order to identify the cell line or authenticate the cell line used for production in drug discovery: CO1 barcode assay. Karyotyping. DNA Analysis – DNA fingerprinting & genotyping. Random Amplification ofPolymorphic DNA.
BIORELIANCE GLASGOW FACILITY INFORMATION BioReliance Glasgow Facility Information. Our Glasgow facility provides clinical manufacturing of intermediates and final products used in viral vaccines and gene therapy products. The Glasgow technical team has years of experience in vaccine manufacturing, having completed its first vaccine manufacture in the early 1990s. ADVENTITIOUS AGENTS / VIROLOGY TESTING Adventitious Agents / Virology Testing. When using cell lines for production of a biotechnology product or biological, adventitious agents are a major concern and In Vitro testing is required according to the ICH guidelines. We perform in vitro assays designed to detect adventitious viruses in cell banks, virus seed stock, raw materialsand
PINNACLE Q-PCR™ HUMAN VIRUS PANEL I BioReliance Biologics Safety Testing Services Pinnacle Q-PCR™ Human Virus Panel I Safety Testing For Human-derived Cells Used In Manufacturing Processes RABBIT PYROGEN / GENERAL SAFETY TEST A pyrogen is a foreign substance that causes a fever (temperature elevation) in an animal’s body. Typically, pyrogenic substances include endotoxin and other bacterial byproducts. Vaccines and other injectable drugs must be confirmed to be pyrogen free according to regulatory requirements of SELECT YOUR COUNTRYCAREERS AT BIORELIANCEABOUT USBIOPHARMACEUTICAL SERVICESCONTACT USINETUNITED STATES Select Your Location Argentina Australia Austria Bangladesh Belgium Brazil Canada Chile China Czech Republic Denmark Egypt France Germany Hungary India Indonesia Iraq Ireland Israel Italy Japan Malaysia Mexico Netherlands New Zealand Nigeria Norway Pakistan Philippines Poland Portugal Russian Federation Singapore Slovakia South AfricaSouth
STERILITY TESTING
Sterility testing of unprocessed and final bulk, final vials, prebanking cells, and cell and virus banks is typically performed by directly inoculating the test article into 2 different types of media that support the growth of aerobic and anaerobic bacteria, respectively. Test articles areHOME | BIORELIANCE
Biomanufacturing Services. BioReliance is dedicated to meeting your manufacturing needs for the production of cell banks, viral seed stocks, and viral vaccines. At BioReliance, we specialize HOME | BIORELIANCETRANSLATE THIS PAGE バイオ受託製造サービス. BioReliance is dedicated to meeting your manufacturing needs for the production of cell banks, viral seed stocks, and viral vaccines. At BioReliance, we specialize VIRUS BANK MANUFACTURING The Virus Bank (Virus Seed, Virus Stock) is a vital part of manufacturing a biological product. The creation of a Master Virus Bank ensures reproducible testing and production of recombinant viruses for the production of vaccines and recombinant proteins. CELL LINE AUTHENTICATION Cell Line Authentication. We offer a variety of services in order to identify the cell line or authenticate the cell line used for production in drug discovery: CO1 barcode assay. Karyotyping. DNA Analysis – DNA fingerprinting & genotyping. Random Amplification ofPolymorphic DNA.
BIORELIANCE GLASGOW FACILITY INFORMATION BioReliance Glasgow Facility Information. Our Glasgow facility provides clinical manufacturing of intermediates and final products used in viral vaccines and gene therapy products. The Glasgow technical team has years of experience in vaccine manufacturing, having completed its first vaccine manufacture in the early 1990s. ADVENTITIOUS AGENTS / VIROLOGY TESTING Adventitious Agents / Virology Testing. When using cell lines for production of a biotechnology product or biological, adventitious agents are a major concern and In Vitro testing is required according to the ICH guidelines. We perform in vitro assays designed to detect adventitious viruses in cell banks, virus seed stock, raw materialsand
PINNACLE Q-PCR™ HUMAN VIRUS PANEL I BioReliance Biologics Safety Testing Services Pinnacle Q-PCR™ Human Virus Panel I Safety Testing For Human-derived Cells Used In Manufacturing Processes RABBIT PYROGEN / GENERAL SAFETY TEST A pyrogen is a foreign substance that causes a fever (temperature elevation) in an animal’s body. Typically, pyrogenic substances include endotoxin and other bacterial byproducts. Vaccines and other injectable drugs must be confirmed to be pyrogen free according to regulatory requirements of SERVICES | BIORELIANCE BioReliance is the leading provider of contract services in the biopharmaceutical industry, supporting every phase of the testing, development and manufacturing process and offering a comprehensive and integrated package of services. Our clients include producers of traditional pharmaceuticals, medical devices, chemicals and otherproducts, as
CONTACT US | BIORELIANCE Tel: +01 301 738 1000. Toll Free: +01 800 553 5372. Fax: +01 301 610 2590. Click here to contact us or. Email Biologics Corporate: info@bioreliance.com. Email Toxicology Corporate: tox@bioreliance.com. BIORELIANCE CARLSBAD FACILITY INFORMATION BioReliance Carlsbad Facility Information. Our manufacturing site in Carlsbad, California is a center of excellence in viral product manufacturing. This facility specializes in the clinical manufacture of intermediates and final products used in viral vaccines and gene therapy products. With its most recent expansion in 2016, the Carlsbad MYCOPLASMA DETECTION Mycoplasma contamination in a cell line may be difficult to detect and is not typically visible with a standard microscope and does not cause any changes to growth media even at high concentrations. We offer regulatory-compliant methods to detect mycoplasma: Agar and semi-solid broth methods. Detection of both cell dependent and cell associated PINNACLE Q-PCR™ HUMAN VIRUS PANEL I BioReliance Biologics Safety Testing Services Pinnacle Q-PCR™ Human Virus Panel I Safety Testing For Human-derived Cells Used In Manufacturing Processes METHOD TRANSFER & VALIDATION Method Validation is essential for adherence to Current Good Manufacturing Practice (cGMP) and Good Laboratory Practice (GLP). In order to meet these needs, we can assist you with method validation, method qualification and method transfer. Analytical Method Validation (AMV) is a requirement within the biopharmaceutical industry for allmethods
CELL LINE CHARACTERIZATION CELL LINE CHARACTERIZATION DNA BARCODE ASSAY For cells that are to be used in GMP biomanufacturing processes, confirmation of cell identity in a Master Cell Bank (MCB) is required1,2.The identification ofspecies though
CO1 BARCODE ASSAY
CO1 Barcode Assay. The cytochrome c oxidase subunit 1 (CO1) gene is an ideal target for species discrimination as this gene is conserved across higher eukaryotes, including insects, fish, birds and mammals. CO1 is located on mitochondrial DNA, meaning it has a relatively fast mutation rate that aligns with speciation timescales.INET
This is a private web portal. Unauthorized access is subject to prosecution to the fullest extent of the law. Please logout from the portal when leaving your computer unattended. For added security, the portal will automatically log you out if left idle for an extended time. Your login information is confidential, please protect it from GENETIC STABILITY TESTING FOR CELL LINES Genetic Stability Testing for Cell Lines All genetic sequences are susceptible to random mutation. Therefore, regulations stipulate that cell lines used as biopharmaceutical manufacturing substrates must betested to ensure
SELECT YOUR COUNTRYCAREERS AT BIORELIANCEABOUT USBIOPHARMACEUTICAL SERVICESCONTACT USINETUNITED STATES Select Your Location Argentina Australia Austria Bangladesh Belgium Brazil Canada Chile China Czech Republic Denmark Egypt France Germany Hungary India Indonesia Iraq Ireland Israel Italy Japan Malaysia Mexico Netherlands New Zealand Nigeria Norway Pakistan Philippines Poland Portugal Russian Federation Singapore Slovakia South AfricaSouth
HOME | BIORELIANCE
Biomanufacturing Services. BioReliance is dedicated to meeting your manufacturing needs for the production of cell banks, viral seed stocks, and viral vaccines. At BioReliance, we specialize CELL LINE AUTHENTICATION Cell Line Authentication. We offer a variety of services in order to identify the cell line or authenticate the cell line used for production in drug discovery: CO1 barcode assay. Karyotyping. DNA Analysis – DNA fingerprinting & genotyping. Random Amplification ofPolymorphic DNA.
VIRUS BANK MANUFACTURING The Virus Bank (Virus Seed, Virus Stock) is a vital part of manufacturing a biological product. The creation of a Master Virus Bank ensures reproducible testing and production of recombinant viruses for the production of vaccines and recombinant proteins. PINNACLE Q-PCR™ HUMAN VIRUS PANEL I BioReliance Biologics Safety Testing Services Pinnacle Q-PCR™ Human Virus Panel I Safety Testing For Human-derived Cells Used In Manufacturing Processes BIORELIANCE GLASGOW FACILITY INFORMATION BioReliance Glasgow Facility Information. Our Glasgow facility provides clinical manufacturing of intermediates and final products used in viral vaccines and gene therapy products. The Glasgow technical team has years of experience in vaccine manufacturing, having completed its first vaccine manufacture in the early 1990s. BIOPHARMACEUTICAL SERVICES (BIOSAFETY TESTING) Biopharmaceutical Services (Biosafety Testing) We are a leading GMP and GLP testing services provider for the development of your therapeutics. Regulatory bodies such as the US Food & Drug Administrators (FDA) and the Medicines and Healthcare products Regulatory Agency (MHRA) require products to be tested for compliancebefore release.
CELL LINE CHARACTERIZATION CELL LINE CHARACTERIZATION DNA BARCODE ASSAY For cells that are to be used in GMP biomanufacturing processes, confirmation of cell identity in a Master Cell Bank (MCB) is required1,2.The identification ofspecies though
INET
This is a private web portal. Unauthorized access is subject to prosecution to the fullest extent of the law. Please logout from the portal when leaving your computer unattended. For added security, the portal will automatically log you out if left idle for an extended time. Your login information is confidential, please protect it from BIORELIANCE TERMS AND CONDITIONS FOR TESTING SERVICES 2 BioReliance® Terms and Conditions for Testing Services v2016 comments are received from Client within thirty (30) days following delivery of the draft report, the SELECT YOUR COUNTRYCAREERS AT BIORELIANCEABOUT USBIOPHARMACEUTICAL SERVICESCONTACT USINETUNITED STATES Select Your Location Argentina Australia Austria Bangladesh Belgium Brazil Canada Chile China Czech Republic Denmark Egypt France Germany Hungary India Indonesia Iraq Ireland Israel Italy Japan Malaysia Mexico Netherlands New Zealand Nigeria Norway Pakistan Philippines Poland Portugal Russian Federation Singapore Slovakia South AfricaSouth
HOME | BIORELIANCE
Biomanufacturing Services. BioReliance is dedicated to meeting your manufacturing needs for the production of cell banks, viral seed stocks, and viral vaccines. At BioReliance, we specialize CELL LINE AUTHENTICATION Cell Line Authentication. We offer a variety of services in order to identify the cell line or authenticate the cell line used for production in drug discovery: CO1 barcode assay. Karyotyping. DNA Analysis – DNA fingerprinting & genotyping. Random Amplification ofPolymorphic DNA.
VIRUS BANK MANUFACTURING The Virus Bank (Virus Seed, Virus Stock) is a vital part of manufacturing a biological product. The creation of a Master Virus Bank ensures reproducible testing and production of recombinant viruses for the production of vaccines and recombinant proteins. PINNACLE Q-PCR™ HUMAN VIRUS PANEL I BioReliance Biologics Safety Testing Services Pinnacle Q-PCR™ Human Virus Panel I Safety Testing For Human-derived Cells Used In Manufacturing Processes BIORELIANCE GLASGOW FACILITY INFORMATION BioReliance Glasgow Facility Information. Our Glasgow facility provides clinical manufacturing of intermediates and final products used in viral vaccines and gene therapy products. The Glasgow technical team has years of experience in vaccine manufacturing, having completed its first vaccine manufacture in the early 1990s. BIOPHARMACEUTICAL SERVICES (BIOSAFETY TESTING) Biopharmaceutical Services (Biosafety Testing) We are a leading GMP and GLP testing services provider for the development of your therapeutics. Regulatory bodies such as the US Food & Drug Administrators (FDA) and the Medicines and Healthcare products Regulatory Agency (MHRA) require products to be tested for compliancebefore release.
CELL LINE CHARACTERIZATION CELL LINE CHARACTERIZATION DNA BARCODE ASSAY For cells that are to be used in GMP biomanufacturing processes, confirmation of cell identity in a Master Cell Bank (MCB) is required1,2.The identification ofspecies though
INET
This is a private web portal. Unauthorized access is subject to prosecution to the fullest extent of the law. Please logout from the portal when leaving your computer unattended. For added security, the portal will automatically log you out if left idle for an extended time. Your login information is confidential, please protect it from BIORELIANCE TERMS AND CONDITIONS FOR TESTING SERVICES 2 BioReliance® Terms and Conditions for Testing Services v2016 comments are received from Client within thirty (30) days following delivery of the draft report, the BIORELIANCE CARLSBAD FACILITY INFORMATION BioReliance Carlsbad Facility Information. Our manufacturing site in Carlsbad, California is a center of excellence in viral product manufacturing. This facility specializes in the clinical manufacture of intermediates and final products used in viral vaccines and gene therapy products. With its most recent expansion in 2016, the Carlsbad CELL LINE AUTHENTICATION Cell Line Authentication. We offer a variety of services in order to identify the cell line or authenticate the cell line used for production in drug discovery: CO1 barcode assay. Karyotyping. DNA Analysis – DNA fingerprinting & genotyping. Random Amplification ofPolymorphic DNA.
BIORELIANCE GLASGOW FACILITY INFORMATION BioReliance Glasgow Facility Information. Our Glasgow facility provides clinical manufacturing of intermediates and final products used in viral vaccines and gene therapy products. The Glasgow technical team has years of experience in vaccine manufacturing, having completed its first vaccine manufacture in the early 1990s.STERILITY TESTING
Sterility testing of unprocessed and final bulk, final vials, prebanking cells, and cell and virus banks is typically performed by directly inoculating the test article into 2 different types of media that support the growth of aerobic and anaerobic bacteria, respectively. Test articles are CELL LINE CHARACTERIZATION Cell Line Characterization is required by the regulatory bodies to confirm the species origin and history of the cell line; and characterize and test the identity, stability and purity: Identity – a required test to confirm the species of the origin and one of the following methods must be performed on a MCB and EOP/CAL. MASTER CELL BANK MANUFACTURING Master Cell Bank Manufacturing. Biologicals such as monoclonal antibodies and recombinant proteins are produced in cultured cell lines from humans, lower mammals, insects, and bacteria. These therapeutic producing cells are typically created through a process that involves: Gene transfection or transformation. Screening forexpression.
HOME | BIORELIANCETRANSLATE THIS PAGE バイオ受託製造サービス. BioReliance is dedicated to meeting your manufacturing needs for the production of cell banks, viral seed stocks, and viral vaccines. At BioReliance, we specialize ADVENTITIOUS AGENTS / VIROLOGY TESTING Adventitious Agents / Virology Testing. When using cell lines for production of a biotechnology product or biological, adventitious agents are a major concern and In Vitro testing is required according to the ICH guidelines. We perform in vitro assays designed to detect adventitious viruses in cell banks, virus seed stock, raw materialsand
BIORELIANCE TERMS AND CONDITIONS FOR TESTING SERVICES 2 BioReliance® Terms and Conditions for Testing Services v2016 comments are received from Client within thirty (30) days following delivery of the draft report, the105230GMP.BSV
Quantitative Product Enhanced Reverse Transcriptase (Q-PERT) Assay for the Detection of Retrovirus in Biological Samples (1 Sample) - GMP SELECT YOUR COUNTRYCAREERS AT BIORELIANCEABOUT USBIOPHARMACEUTICAL SERVICESCONTACT USINETUNITED STATES Select Your Location Argentina Australia Austria Bangladesh Belgium Brazil Canada Chile China Czech Republic Denmark Egypt France Germany Hungary India Indonesia Iraq Ireland Israel Italy Japan Malaysia Mexico Netherlands New Zealand Nigeria Norway Pakistan Philippines Poland Portugal Russian Federation Singapore Slovakia South AfricaSouth
SERVICES | BIORELIANCE BioReliance is the leading provider of contract services in the biopharmaceutical industry, supporting every phase of the testing, development and manufacturing process and offering a comprehensive and integrated package of services. Our clients include producers of traditional pharmaceuticals, medical devices, chemicals and otherproducts, as
HOME | BIORELIANCE
Biomanufacturing Services. BioReliance is dedicated to meeting your manufacturing needs for the production of cell banks, viral seed stocks, and viral vaccines. At BioReliance, we specialize MASTER CELL BANK MANUFACTURING Master Cell Bank Manufacturing. Biologicals such as monoclonal antibodies and recombinant proteins are produced in cultured cell lines from humans, lower mammals, insects, and bacteria. These therapeutic producing cells are typically created through a process that involves: Gene transfection or transformation. Screening forexpression.
CELL LINE AUTHENTICATION Cell Line Authentication. We offer a variety of services in order to identify the cell line or authenticate the cell line used for production in drug discovery: CO1 barcode assay. Karyotyping. DNA Analysis – DNA fingerprinting & genotyping. Random Amplification ofPolymorphic DNA.
HOME | BIORELIANCETRANSLATE THIS PAGE バイオ受託製造サービス. BioReliance is dedicated to meeting your manufacturing needs for the production of cell banks, viral seed stocks, and viral vaccines. At BioReliance, we specialize BIORELIANCE GLASGOW FACILITY INFORMATION BioReliance Glasgow Facility Information. Our Glasgow facility provides clinical manufacturing of intermediates and final products used in viral vaccines and gene therapy products. The Glasgow technical team has years of experience in vaccine manufacturing, having completed its first vaccine manufacture in the early 1990s. PINNACLE Q-PCR™ HUMAN VIRUS PANEL I BioReliance Biologics Safety Testing Services Pinnacle Q-PCR™ Human Virus Panel I Safety Testing For Human-derived Cells Used In Manufacturing Processes ADVENTITIOUS AGENTS / VIROLOGY TESTING Adventitious Agents / Virology Testing. When using cell lines for production of a biotechnology product or biological, adventitious agents are a major concern and In Vitro testing is required according to the ICH guidelines. We perform in vitro assays designed to detect adventitious viruses in cell banks, virus seed stock, raw materialsand
INET
This is a private web portal. Unauthorized access is subject to prosecution to the fullest extent of the law. Please logout from the portal when leaving your computer unattended. For added security, the portal will automatically log you out if left idle for an extended time. Your login information is confidential, please protect it from SELECT YOUR COUNTRYCAREERS AT BIORELIANCEABOUT USBIOPHARMACEUTICAL SERVICESCONTACT USINETUNITED STATES Select Your Location Argentina Australia Austria Bangladesh Belgium Brazil Canada Chile China Czech Republic Denmark Egypt France Germany Hungary India Indonesia Iraq Ireland Israel Italy Japan Malaysia Mexico Netherlands New Zealand Nigeria Norway Pakistan Philippines Poland Portugal Russian Federation Singapore Slovakia South AfricaSouth
SERVICES | BIORELIANCE BioReliance is the leading provider of contract services in the biopharmaceutical industry, supporting every phase of the testing, development and manufacturing process and offering a comprehensive and integrated package of services. Our clients include producers of traditional pharmaceuticals, medical devices, chemicals and otherproducts, as
HOME | BIORELIANCE
Biomanufacturing Services. BioReliance is dedicated to meeting your manufacturing needs for the production of cell banks, viral seed stocks, and viral vaccines. At BioReliance, we specialize MASTER CELL BANK MANUFACTURING Master Cell Bank Manufacturing. Biologicals such as monoclonal antibodies and recombinant proteins are produced in cultured cell lines from humans, lower mammals, insects, and bacteria. These therapeutic producing cells are typically created through a process that involves: Gene transfection or transformation. Screening forexpression.
CELL LINE AUTHENTICATION Cell Line Authentication. We offer a variety of services in order to identify the cell line or authenticate the cell line used for production in drug discovery: CO1 barcode assay. Karyotyping. DNA Analysis – DNA fingerprinting & genotyping. Random Amplification ofPolymorphic DNA.
HOME | BIORELIANCETRANSLATE THIS PAGE バイオ受託製造サービス. BioReliance is dedicated to meeting your manufacturing needs for the production of cell banks, viral seed stocks, and viral vaccines. At BioReliance, we specialize BIORELIANCE GLASGOW FACILITY INFORMATION BioReliance Glasgow Facility Information. Our Glasgow facility provides clinical manufacturing of intermediates and final products used in viral vaccines and gene therapy products. The Glasgow technical team has years of experience in vaccine manufacturing, having completed its first vaccine manufacture in the early 1990s. PINNACLE Q-PCR™ HUMAN VIRUS PANEL I BioReliance Biologics Safety Testing Services Pinnacle Q-PCR™ Human Virus Panel I Safety Testing For Human-derived Cells Used In Manufacturing Processes ADVENTITIOUS AGENTS / VIROLOGY TESTING Adventitious Agents / Virology Testing. When using cell lines for production of a biotechnology product or biological, adventitious agents are a major concern and In Vitro testing is required according to the ICH guidelines. We perform in vitro assays designed to detect adventitious viruses in cell banks, virus seed stock, raw materialsand
INET
This is a private web portal. Unauthorized access is subject to prosecution to the fullest extent of the law. Please logout from the portal when leaving your computer unattended. For added security, the portal will automatically log you out if left idle for an extended time. Your login information is confidential, please protect it from SERVICES | BIORELIANCE BioReliance is the leading provider of contract services in the biopharmaceutical industry, supporting every phase of the testing, development and manufacturing process and offering a comprehensive and integrated package of services. Our clients include producers of traditional pharmaceuticals, medical devices, chemicals and otherproducts, as
MASTER CELL BANK MANUFACTURING Master Cell Bank Manufacturing. Biologicals such as monoclonal antibodies and recombinant proteins are produced in cultured cell lines from humans, lower mammals, insects, and bacteria. These therapeutic producing cells are typically created through a process that involves: Gene transfection or transformation. Screening forexpression.
STERILITY TESTING
Sterility testing of unprocessed and final bulk, final vials, prebanking cells, and cell and virus banks is typically performed by directly inoculating the test article into 2 different types of media that support the growth of aerobic and anaerobic bacteria, respectively. Test articles are BIORELIANCE CARLSBAD FACILITY INFORMATION BioReliance Carlsbad Facility Information. Our manufacturing site in Carlsbad, California is a center of excellence in viral product manufacturing. This facility specializes in the clinical manufacture of intermediates and final products used in viral vaccines and gene therapy products. With its most recent expansion in 2016, the Carlsbad VIRUS BANK MANUFACTURING The Virus Bank (Virus Seed, Virus Stock) is a vital part of manufacturing a biological product. The creation of a Master Virus Bank ensures reproducible testing and production of recombinant viruses for the production of vaccines and recombinant proteins. HOME | BIORELIANCETRANSLATE THIS PAGE バイオ受託製造サービス. BioReliance is dedicated to meeting your manufacturing needs for the production of cell banks, viral seed stocks, and viral vaccines. At BioReliance, we specialize CELL LINE AUTHENTICATION Cell Line Authentication. We offer a variety of services in order to identify the cell line or authenticate the cell line used for production in drug discovery: CO1 barcode assay. Karyotyping. DNA Analysis – DNA fingerprinting & genotyping. Random Amplification ofPolymorphic DNA.
CAREERS AT BIORELIANCE In 2013, nearly 20% of our hires were employee referrals or rehires and the trend is continuing in 2014. The average tenure of our employees is impressive: Account Manager = 6 years. Laboratory Managers = 17 years. Laboratory Supervisor = 8 years. Principal Scientist = 10 years. Project Manager = 8 years. Report Writer = 10years.
CELL LINE CHARACTERIZATION Cell Line Characterization is required by the regulatory bodies to confirm the species origin and history of the cell line; and characterize and test the identity, stability and purity: Identity – a required test to confirm the species of the origin and one of the following methods must be performed on a MCB and EOP/CAL.CO1 BARCODE ASSAY
CO1 Barcode Assay. The cytochrome c oxidase subunit 1 (CO1) gene is an ideal target for species discrimination as this gene is conserved across higher eukaryotes, including insects, fish, birds and mammals. CO1 is located on mitochondrial DNA, meaning it has a relatively fast mutation rate that aligns with speciation timescales. SELECT YOUR LOCATIONUNITED STATES
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