cGMP Manufacturing /
cGMP manufacturing of Master and Working Cell Banks (MCB/WCB):
- Microbial and mammalian MCB and WCB manufacturing in separate areas. Aseptic Cell banking activities is performed within certified laminar flow II biosafety level cabinets with HEPA filtered air Class A. Cells are grown only in qualified incubators.
- Characterization/testing of MCB/WCB following regulatory guidelines: ICH Q5B, Q5D, Q5A, Q6B, Q7.
- Stability studies.
- Storage of a portion of the MCB and WCB at a remote site under cGMP conditions in vapour phase of liquid nitrogen vessels or in deep freezers (i.e. -80 C) . Banks are divided and stored in separate freezers to prevent loss due to freezer malfunction. A monitoring system confirms proper liquid nitrogen levels and freezer temperatures around the clock. A fully redundant backup system ensures security of the storage facility. We certify that mammalian cell lines are free of mycoplasma and bacterial contamination.