cGMP Cell Banking By Florida Biologix

Florida Biologix manufactures Master Cell Banks (MCB) and Working Cell Banks (WCB) in two segregated and independent ISO 7 small scale cell culture bays with dedicated gown-in and gown-out rooms. The bays contain biosafety cabinets, cold storage, CO2 incubators and centrifuges.

Once developed, tested, grown and frozen in controlled rate freezers, the banks are stored in validated ultra-low liquid nitrogen freezers which are continuously monitored.

Cell banks manufactured and tested by Florida Biologix comply with cGMP regulations and FDA regulatory agency requirements. Florida Biologix tests include microbial sterility, mycoplasma contamination, cell line characterization and in vivo and in vitro adventitious and endogenous viral tests.

Florida Biologix is capable of providing up to 200 vials of the MCB or WCB to our clients. To ensure protection of the bank, one half of the MCB vials may be stored in an offsite commercial cGMP-compliant facility.

IN-HOUSE QUALITY CONTROL AND QUALITY ASSURANCE: QC provides facility environmental monitoring procedures and a full battery of analytical methods. QA provides audited Production Batch Records, product release and other appropriate regulatory documentation.