Confirm the identity of cell lines in your laboratory
Regulatory bodies request genetic characterization of cell lines and recombinant protein products, to confirm the species of origin and to monitor and control the genetic stability across the production process. Even in highly controlled facilities, random mutations will occur during culture expansions.
- Identity: Determine the species origin vector identity. Required by regulatory authorities (FDA, WHO).
- Genetic stability: Measure genetic alterations due to the culture expansion process, such as SNPs, insertions/deletions (InDels) and Copy Number Variations (CNVs). This test compares the genetic information of the Working Cell Bank (WCB) or End Of Production Cells (EOPC) with the Master Cell Bank (MCB) reference.
- Purity: Proves the absence of adventitious agents such as bacteria, fungi and viruses.
GenomeScans expertise in the recommendations of regulatory authorities helps you to adhere to all guidelines for safety testing and/or to markedly reduce the time to set up a stable production line.