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Cell Banking
Wuxi Advanced Therapies offers expert cell banking services compliant with global regulatory standards, ensuring a continuous supply of specific cell lineages crucial for biopharmaceutical manufacturing. Their comprehensive process includes batch record development, cell expansion and harvest, as well as thorough testing and characterization of the cell lines. The advanced therapies unit focuses on the rapid development and commercialization of cell and gene therapies, providing integrated contract development and manufacturing solutions.
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Cell Banking
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- 2. Regulatory agencies worldwiderequire a continuing and well-controlled supply of the specific cell lineage that is integral to the manufacturing process of a biopharmaceutical. Let WuXi Advanced Therapies’team of experienced cell culture specialists – with the oversight of our highly trained quality assurance unit – manufacture your banks to the highest standards to meet global expectations. Batch Record Development • Consultation to determine needs • Clarify raw materials and process requirements • Creation of a batch record to document a comprehensive cell line history, growth profile and safety & characterization data ex p e r t i se Cell Expansion & Harvest • Capacity to manufacture 10-1,200 vials • Campaign production approach • Stringent raw materials release program • Thorough seed stock contamination acceptance screening • Validated change-over and cleaning procedures Testing & Characterization • Recovery viability • Growth • Complete biosafety • Genetic characterization Documentation • 100% QA raw data review • QA-approved Certificate of Analysis Human 324K A549 BJAB CEM-A HEK 293 H9 HeLa Hs-68 HT-1080 MRC-5 MSC Neuroblastoma PER-C6 RD Spleen TALL264 Umbilical cord WI-38 Bovine BT MDBKs Monkey B-95 CV-1 LLC MK2 MA104 VERO Murine BALB 3T3 Hybridoma L929 NSO Mus dunni NIH 3T3 SC-1 Sp2/0 Porcine PK-15 PT-1 ST Rat XC CELL BANKING EXPERIENCE CELL CULTURE PLATFORMS T-Flasks • Shaker Flasks Spinner Flasks • Roller Bottles Cell Factories • Hyperstacks Canine MDCK Chicken Embryo Equine NBL-6 Feline PG4 Hamster BHK-21 CHO Insect Drosophila High-5 S2 Sf9 Mink *Includes cell, cell line banking for both GMP and testing purposes
- 3. Regulatory agencies worldwiderequire a continuing and well-controlled supply of the specific cell lineage that is integral to the manufacturing process of a biopharmaceutical. Let WuXi Advanced Therapies’team of experienced cell culture specialists – with the oversight of our highly trained quality assurance unit – manufacture your banks to the highest standards to meet global expectations. Batch Record Development • Consultation to determine needs • Clarify raw materials and process requirements • Creation of a batch record to document a comprehensive cell line history, growth profile and safety & characterization data ex p e r t i se Cell Expansion & Harvest • Capacity to manufacture 10-1,200 vials • Campaign production approach • Stringent raw materials release program • Thorough seed stock contamination acceptance screening • Validated change-over and cleaning procedures Testing & Characterization • Recovery viability • Growth • Complete biosafety • Genetic characterization Documentation • 100% QA raw data review • QA-approved Certificate of Analysis Human 324K A549 BJAB CEM-A HEK 293 H9 HeLa Hs-68 HT-1080 MRC-5 MSC Neuroblastoma PER-C6 RD Spleen TALL264 Umbilical cord WI-38 Bovine BT MDBKs Monkey B-95 CV-1 LLC MK2 MA104 VERO Murine BALB 3T3 Hybridoma L929 NSO Mus dunni NIH 3T3 SC-1 Sp2/0 Porcine PK-15 PT-1 ST Rat XC CELL BANKING EXPERIENCE CELL CULTURE PLATFORMS T-Flasks • Shaker Flasks Spinner Flasks • Roller Bottles Cell Factories • Hyperstacks Canine MDCK Chicken Embryo Equine NBL-6 Feline PG4 Hamster BHK-21 CHO Insect Drosophila High-5 S2 Sf9 Mink *Includes cell, cell line banking for both GMP and testing purposes
- 4. The Advanced Therapiesbusiness unit of WuXi AppTec is a global Contract Development and Manufacturing Organization dedicated to accelerating and transforming development, manufacturing, and commercialization of cell, gene, and other advanced therapies. Accelerating Progress and Time to Market Integrated CDMO and Testing Service Platform advancedtherapies.com CONNECT WITH US WuXiATU-112-110118