Genetic Stability of Cell Lines
Regulatory approval of biopharmaceuticals produced in cell recombinant cell substrates requires extensive analysis to demonstrate the recombinant DNA gene expression system is stable. Detailed genetic stability testing of cell banks is a key component for a BLA application, and smaller scale studies for and IND submission are recommended.

Eukaryote and prokaryote cell banks containing integrated vectors or plasmids require molecular analysis of the expression system and some also require analysis of the mRNA transcript that encodes the gene product. Our team has many years of expertise in genetic stability studies and the analysis of recombinant cell lines. In particular our experience is in the methodologies required which include gene copy number by qPCR, mRNA and genomic DNA sequencing, Southern and Northern blotting techniques.

Specific services will include:

• Gene Copy Number by qPCR
• Insertion Site Number
• DNA Sequencing
• mRNA Sequencing
• Northern Blot Analysis
• Southern Blot Analysis

Regulatory services are designed with full adherence to relevant regulations and guidelines.

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