GMP Cell Banking - WuXi AppTec

1 Mammalian SuspensionGMP Cell Bankingfor Mammalian and Microbial Production SystemsExacting standards, quality and facilitiesto meet your expectationsMammalian AdherentBacteriaYeastRegulatory agencies worldwide require a continuing supply of the speci c cell lineage that is integral to the manufacturing process of a biopharmaceutical. Let WuXi AppTec 's team of experienced cell culture and fermentation specialists, with the oversight of our highly trained quality assurance unit, perform these critical IND- and BLA-enabling AppTec manufactures mammalian and microbial cell banks under strict GMP guidelines and quality oversight for regulatory submissions worldwideWith each cell bank, WuXi AppTec partners with the client to develop a client-speci c batch record, expedited by direct, open communications between WuXi AppTec 's scienti c sta and the client's tissue culture specialist.

2 Likewise, all raw material requirements will be discussed and agreed upon prior to nalizing the batch record. WuXi AppTec will help deliver the requisite information that will assist clients in documenting the comprehensive cell line history, growth pro le and safety & charac- terization data that is integral for worldwide regulatory EXPANSION AND HARVESTMany di erent species of mammalian, insect and microbial cell banks ranging in size from 10 to 1,200 vials can be manufactured using a variety of media types. Both adherent and suspension cells can be grown using cell culture methods that include T- asks, roller bottles, shaker and spinner asks, and cell factories or hyperstacks for larger cell expansion projects.

3 Once the client provides the seed stock material to WuXi AppTec and prior to entering the GMP space, the cells are rst tested for adventitious agents. Concurrent with this testing, the raw materials for the GMP bank will be ordered, received and tested (if required) and the batch record prepared and nalized by the project team. When released for GMP manufacturing, the cells are expanded to the requisite cell number to ll the agreed-upon number of cryovials for the cell cell banks are strictly segregated and produced on a campaign basis ( , one cell bank is produced within each suite at a time).

4 Validated changeover and cleaning procedures requiring Quality Assurance release of each suite prior to use ensure cell line integrity and minimize adverse events and contamination. Raw materials used for the production of the cell banks are obtained from QA-approved vendors or the client may provide these materials to WuXi AppTec to be released under WuXi AppTec s QA raw material release program. If required, WuXi AppTec can perform serum-free, animal protein-free or suspension adaptations of the cell lines prior to RECORD DEVELOPMENTTESTING / CHARACTERIZATIONCell banks created at WuXi AppTec are tested for recovery viability and growth after cryopreservation.

5 Comprehensive in-house testing services are also available for complete biosafety and characterization of the cell banks under FDA and ICH LINE EXPERIENCEH umanEmbryonic Retina (PER-C6)Spleen Kidney (MRC-5)Neuroblastoma cellsEmbryonic Kidney (HEK 293)Umbilical cord MurineHybridomaHybridoma Sp2/0 Myeloma (NSO) MonkeyAfrica Green Monkey (VERO)Rhesus Monkey (LLC MK2) InsectDrosophila S2 Fall armyworm Sf9 HamsterOvary (CHO)CanineKidney (MDCK) ChickenEmbryoMicrobialE. coliPichia pastorisSaccharomyces cerevisiaeCELL CULTURE PLATFORMST-FlasksShaker Flasks Spinner FlasksRoller BottlesCell FactoriesREPORTSA QA-approved Certi cate of Analysis will be issued, including a copy of all cell bank manufacturing, harvest and freezing documentation and viability data.

6 If biosafety and characterization testing is conducted by WuXi AppTec on the cell bank, individual assay reports supported by 100% QA review of raw data will also be provided to support regulatory lines are frozen at a controlled rate to minimize freeze-related trauma prior to storage in the vapor phase of liquid banks can be stored long term at WuXi AppTec in highly controlled and regulated GMP storage facilities. Various levels of segregation (including client-dedicated freezers) can be reserved for your cell bank within the vapor phase of liquid GMP cell Banking facilities at WuXi AppTec are a highly monitored, secure, and controlled environment.

7 All work is Batch Record- and SOP-driven and documented, and performed in ultra-clean suites by gowned, highly skilled AppTec maintains seven (7) individually monitored GMP mammalian cell Banking suites and a segregated and separate 360-square-foot microbial cell Banking space. Our GMP manufacturing is conducted in individually equipped, positive-pressure suites with Class 5 laminar ow hoods. All suites are HEPA ltered and the rooms and equipment are continuously monitored and alarmed. Validated systems and procedures, as well as routine environmental monitoring, ensure the highest quality in aseptic processing.

8 cells are grown within temperature-mapped and validated suite complex operates under a stringent security program, which includes 21 CFR, Part 11-compliant computer systems, redundant tem- perature monitoring, re protection, and an auxiliary back-up power generator. In addition, the entire facility is monitored by a security system tied into a central station where a 24-hour watch is main- tained on system , STORAGE AND SHIPMENTR egulatory agencies worldwide require a continuing supply of the speci c cell lineage that is integral to the manufacturing process of a biopharmaceutical.

9 Let WuXi AppTec 's team of experienced cell culture and fermentation specialists, with the oversight of our highly trained quality assurance unit, perform these critical IND- and BLA-enabling AppTec manufactures mammalian and microbial cell banks under strict GMP guidelines and quality oversight for regulatory submissions worldwideWith each cell bank, WuXi AppTec partners with the client to develop a client-speci c batch record, expedited by direct, open communications between WuXi AppTec 's scienti c sta and the client's tissue culture specialist. Likewise, all raw material requirements will be discussed and agreed upon prior to nalizing the batch record.

10 WuXi AppTec will help deliver the requisite information that will assist clients in documenting the comprehensive cell line history, growth pro le and safety & charac- terization data that is integral for worldwide regulatory EXPANSION AND HARVESTMany di erent species of mammalian, insect and microbial cell banks ranging in size from 10 to 1,200 vials can be manufactured using a variety of media types. Both adherent and suspension cells can be grown using cell culture methods that include T- asks, roller bottles, shaker and spinner asks, and cell factories or hyperstacks for larger cell expansion projects.