Genetic Stability Testing (Locus Amplification & Sequencing + ddPCR)
Genetic stability testing is a crucial component in the characterization of production cell banks and is mandated by regulatory authorities. Mammalian production cell lines are commonly established through the stable transfection of the expression vector into the host cell line. Nevertheless, genetic alterations, such as deletions, rearrangements, and mutations, may arise during cell culture, resulting in modifications to cell behavior and gene expression. The instability of cell lines is a significant cause for concern as it has the potential to impact the quality of products and pose risks to patients. Even in cases where product quality is not immediately compromised, reduced productivity and an increased likelihood of future issues remain worrying from an operational perspective.
Genetic stability testing entails a variety of assessments usually performed on the master cell banks (MCB) and a batch of end-of-production cells (EOPC) from a manufacturer. Furthermore, genetic stability testing of the working cell banks (WCB) may also be conducted at the manufacturer's discretion. Through comparing the results of the EOPC and WCB with those of the MCB, any deviations indicating potential instability in the cell line can be detected.
With many years of experience and in-depth knowledge, Creative Bioarray offers Genetic stability Testing ((Locus Amplification & Sequencing + ddPCR) for you. We guarantee the speed, quality and cost of our service.
Techniques Available:
Creative Bioarray offers the efficient techniques available for evaluating the stability of cell lines throughout the cell line development process, including:
Measuring the integrity of the product transcript:
- Transgene Mapping (Locus Amplification & Sequencing)
- mRNA/cDNA sequencing
Identifying the genomic structure at the integration site
- Transgene Mapping (Locus Amplification & Sequencing)
Measuring the ratio of insert gene copy number relative to host genome
- ddPCR
Determining transcript size
- Transgene Mapping (Locus Amplification & Sequencing)
The approach to genetic analysis and stability testing may differ based on the production setup and project stage. Our regulatory specialists can offer support to help align your program with regulatory standards.
Quotation and ordering
Our customer service representatives are available 24hr a day! We thank you for choosing Creative Bioarray at your preferred Genetic Stability Testing (Locus Amplification & Sequencing + ddPCR).
