ST Cell Line (MCB, WCB, EOPC) Genetic Stability Testing
Swine testis (ST) cells are regarded as one of cell lines most suitable for producing vaccines against pseudorabies virus. Creative Bioarray offers the ST Cell Line (MCB, WCB, EOPC) Genetic Stability Testing using different methods, including qPCR, Locus Amplification & Sequencing, FISH and DNA and RNA sequencing.
| Genetic Tests | Creative Bioarray Solutions for Genetic Stability Testing | Description |
|---|
| Gene Copy Number |
qPCR or Locus Amplification & Sequencing |
To ensure that the gene of interest is stably maintained and expressed during the whole usable life span of the cell clone, specific qPCR assays for gene copy number determination are designed and validated. |
| Integrity of the Transgene |
DNA and RNA sequencing |
Genetic stability of an insert within e.g. a cell bank has to be demonstrated. By using Sanger sequencing, the sequence/location of the insert can be compared to the reference sequence and possible mutations/deletions can be detected. |
| Structural Analysis (transgene insertion sites/restriction analysis) |
qPCR or Locus Amplification & Sequencing |
To ensure that the gene of interest is stably maintained and expressed during the whole usable life span of the cell clone, specific qPCR assays for gene copy number determination are designed and validated. |
| Integrity Pattern of the Transgene |
FISH |
To ensure that the gene of interest is stably maintained and expressed during the whole usable life span of the cell clone |
The testing of a cell line's genetic stability (Master Cell Bank, Working Cell Bank, End of Production) is a critical step in the production process. This testing is important for ensuring the safety, consistency, and efficacy of biopharmaceutical products.
- Firstly, genetic stability testing of the cell line ensures that the cell's genetic material has not been altered significantly during culture or storage. Any unwarranted changes to the genes might lead to changes in the cell's behavior, possibly causing it to produce harmful byproducts or reducing its ability to produce the desired product.
- Secondly, consistent results from genetic stability testing over time are essential in confirming the reproducible nature of the production process. This guarantees that the same quality and quantity of a product are produced consistently from the cell line, ensuring predictability and reliable supply of the product to the market.
- Finally, genetic stability testing is mandated by regulatory bodies worldwide such as the FDA and EMEA. Passing such tests is a prerequisite for the approval of a biopharmaceutical product for release into the market.
Genetic stability testing of MCB, WCB, and EOPC is of utmost importance for the safe and efficient production of biopharmaceuticals.
Genetic Stability Testing Methods
Creative Bioarray applies the following methods to determine the genetic stability test of recombinant ST production cell lines:
- Transgene insertion copy number analyzed by qPCR and/or Locus Amplification & Sequencing
- Structural analysis (insertion sites/restriction analysis) by qPCR and/or Locus Amplification & Sequencing
- Transgene integrity pattern analysis by FISH
- DNA and RNA sequencing
The ST Cell Line (MCB, WCB, EOPC) Genetic Stability Testing Features:
- Genetic stability analysis across various generations (e.g., MCB, WCB, EOP)
- In accordance with ICH Q5B and Q5D guidelines
- Final conclusions on stability of analyzed cell bank(s)
- Reporting meeting regulatory requirements
- Pre-finalization report review included
- Fast turnaround time
Quotation and ordering
Our customer service representatives are available 24hr a day! We thank you for considering Creative Bioarray as your ST Cell Line (MCB, WCB, EOPC) Genetic Stability Testing Service partner.
All products and services on this website are only suitable for non-medical purposes.
