Genetic QC to de-risk cell line development:
Zooming in on clonality assurance & clone selection
Thursday 2 December 2021 - 4 PM CET / 10 AM ET
In recent years, there has been a surge in interest for proof of monoclonality. Irrefutably, clonality represents a critical step in stable cell line development and is a topic that is also closely monitored by regulatory authorities (e.g. FDA, EMA). Besides being requested by officials, comprehensive genetic characterization and subsequent in-depth genetic documentation will help you provide stronger evidence and assurance of clonal derivation of your producer cell lines, toward guaranteeing consistent and safe production of high quality products (e.g. antibodies, viral vectors, etc.).
Another important issue during the development of stable recombinant cell lines, is to identify high-producing clones. On this note, early clone screening - selecting clones that carry the desired genetic features - will allow you to de-risk R&D decisions and accelerate time to clinic.
In this webinar, we will zero in on these important topics. Therefore, you can expect to learn about:
- Genetic QC requirements mandated by regulatory authorities
- Challenges in demonstrating the clonal origin of (CHO) legacy cell lines
- A robust approach to provide proof of clonality and support regulatory filings
- How to speed up timelines and de-risk developments in the CLD workflow
- Clone selection and ensuring optimal genetic characteristics in MCB for GMP manufacturing
- Cergentis' new CHOice platform for in-house CHO clone selection
The webinar will be concluded with a Q&A.
Your host:
Natalia Loaiza, MSc
Sales & Account Manager - Cell Line Development
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