Genetic stability
Cell banks used to produce recombinant proteins, monoclonal antibodies, vaccines and gene therapy products contain genetic constructions that need to be verified.
Depending on the type of cell bank (eukaryotic or prokaryotic) and genetic construction (integrated construction or free-replicating plasmid), different genetic tests can be done to evaluate the safety and suitability of the banks:
- Regulatory compliant sequencing of the genetic construction or the mRNA produced
- Plasmid retention by PCR or qPCR
- Plasmid structure by restriction mapping
- Construction of copy number by qPCR
- Host cell identification by DNA fingerprinting or sequencing