GMP Facilities
Celltechna provides cGMP Master and Working Cell Banks (MCB/WCB) upstream (Microbial and Mammalian) and downstream GMP Batch production with a 2 c cmD JPC laboratory, a cGMP laboratory area of approximately 350 m2 (clean room) for clinical trial biopharmaceuticals and cell therapy.
Cell Banking Capabilities
- Characterization and testing of MCBs and WCBs according to ICH Q5B, Q5D, Q5A, Q6B and Q7 guidelines
- Aseptic cell banking within certified laminar flow II biosafety level cabinets with Class A high-efficiency particulate air (HEPA)
- Stability studies
We characterize cell banks according to all applicable ICH guidelines, employing testing methods specific to the cell line used for your production. Cells are grown in the appropriate incubators, and microbial and mammalian cell banking activities are conducted in completely separate areas. We certify that mammalian cell lines are free of mycoplasma and bacterial contamination.
For risk mitigation, we store a portion of our clients’ MCBs and WCBs offsite under cGMP conditions, either in vapor phase of liquid nitrogen vessels or in deep freezers (-80º C), with a monitoring system to confirm proper liquid nitrogen levels and freezer temperatures at all times. Banks are separated and stored in individual freezers at two different locations to prevent loss due to freezer malfunction, and a fully redundant backup system ensures security of the storage facility.
In addition to the infrastructure and technical expertise, extensive QA and QC are performed, and regulatory experience is available to ensure the necessary compliance during the development of each specific cellular product.
Capacities and capabilities
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Equipment (2)