Cell Bank Characterization

Cell Bank Characterization

Cell banks are the critical components in the biopharmaceutical industry. Hence, prior to evaluating the biosafety of cell-derived products, it is essential to perform a comprehensive characterization analysis in order to guarantee the purity and safety of the cell banks. A well-characterized cell bank provides a reliable source of contaminant-free production. As described in the FDA, ICH and EMEA guidelines, the recommended assays are partially different depending on the type of producing cell bank.

The biosafety package for any biopharmaceutical product must include an appropriate and specific plan for evaluation the cell line identity and its recombinant genome stability as well as detection of endogenous and adventitious agents such as bacteria, mycoplasma, fungi or viruses. These cell bank characterization services enable production of biologicals free of molecular, cellular, and viral safety assays for the mammalian, insect, and microbial cell lines at the level of the Master, Working, and End of Production Cell Banks. in the following page, the recommended tests will be listed according to the ICH guidelines and Pharmacopeia.

The recommended test for MCB, WCB and EPCB

Identity

  • DNA Barcoding Analysis
  • DNA Fingerprinting
  • Species-Specific Real-Time PCR

Purity

  • Mycoplasma Contamination Detection (Culture method and Indicator cells)
  • Mycoplasma Contamination Detection (Real Time PCR-based analysis)

 

Sterility

  • Bacteria and Fungi Contamination
  • Bacteriostasis and Fungistasis

Genetic Stability Assessment

  • Transgene insertion/Plasmid copy number by qPCR
  • DNA Sequencing Analysis
  • RNA Sequencing Analysis
  • Restriction map analysis
  • DNA stability
  • RNA stability
  • Gene Cloning

Bacteriophage Testing

  • Detection of lytic and lysogenic phages by plaque assay Retrovirus Test
  • Transmission Electron Microscopy (TEM)
  • Infectivity (Extended XC plaque assay/Extended S+L- focous assay)
  • Reverse Transcriptase Assay using PERT Assay

In vivo Assay

  • Testing the presence of adventitious viruses using Adult, Suckling mice, and Embryonated eggs

In vitro Assay

  • 28/14 day in vitro assay for presence of viral contamination using three cell

Antibody Production Test

  • Mouse Antibody Production Test (MAP), Hamster Antibody Production Test (HAP), Rat Antibody Production Test (RAP)

qPCR Test

  • Bovine viruses, Porcine viruses, Human viruses