The Expertise of Bio Elpida in the Production of GMP Cell Bank

Primary cell bank, research bank, MCB, WCB et End of Product Cell Bank

Bio Elpida proposes the production of prokaryote and eukaryote cell banks under GMP conditions. This production includes characterization and QC control of the cell banks.

The banks proposed are:

• Primary Banks,
• Research Banks,
• Master Cell Bank,
• Working Cell Bank,
• End of Production Cell Bank.
  
  

Cell bank production was declared and is part of the activity of the establishment authorized by the ANSM (French Medical Regulatory Agency) for producing MPUP. These operations are performed in the pharmaceutical zone and are compliant with current regulation and guidelines (Q5A, Q5B, Q5D, CFR21 part 680, GMP annexe 3…).