Genetic Stability Testing

Genetic stability testing (cell line stability) is a key component in characterizing production cell banks and is critical in maintaining quality assurance of biologicals derived from bacterial, yeast, and mammalian cell cultures. Performing genetic stability studies verifies that the expression system has not undergone any changes that would impact product integrity.

Conducted in Phase 3 using the master cell bank (MCB) or End-of-Production/Cell at Limit (EOP/CAL), genetic stability is confirmed using various methods:

• Restriction enzyme analysis by Southern Blot
• Gene copy number by QPCR
• Expression Cassette Sequencing
• Fluorescence In Situ Hybridization (FISH) – gene mapping
• Karyology – classical & spectral