GMP Cell Line Certification

Immunology data packages for the qualification of cells for the GMP production of proteins or peptides or other biotherapeutics in compliance with ICH Q5B and Q5D. At various stages throughout the process, namely the master cell bank (MCB), working cell banks (WCB) and the end of production cells (EPC), cultures are tested for viral contaminants by electron microscopy Flow Cytometry; isoenzyme analysis; genetic stability of the transgene by copy number verification, genomic mapping and sequencing.