Source fetal bovine serum, trypsin and other animal-derived products may be redundantly tested to verify absence of adventitious agents. Cell lines are strictly segregated to prevent cross-contamination. Mycoplasma and sterility assays are performed on all cell lines prior to culture initiation. Our cryopreservation system includes rate-freezing capabilities. Cells are cultivated and expanded in antibiotic-free medium until a sufficient number of cells are obtained to produce whatever quantity specified by the client.
All documentation is multi-reviewed for accuracy and completeness.
A Quality Assurance program ensures document control and compliance with cGMP, protocols, SOPs and any pertinent regulations.