Innovative solutions to guarantee the quality of your cell therapy products
Thursday 28 October 2021 - 4 PM CET / 10 AM ET
Given the surge in R&D activities related to the Cell & Gene Therapy (CGT) application, Advanced Therapy Medicinal Products (ATMP) are expected to continue to flourish in the coming years. With this comes increased scrutiny from regulatory authorities. CGT manufacturers will need to satisfy stringent requirements, in order to demonstrate the safety and efficacy of their manufactured products. Therefore, there is a growing need within the pharmaceutical, biotech and CDMO space to implement improved analytical tools, to streamline a robust GMP-compliant manufacturing process. On this note, identifying the right assay(s) for comprehensive genetic characterization will be essential, toward meeting the genetic QC requirements mandated by the FDA and EMA.
Within this context, we will present insightful case studies to highlight some of the most pressing genetic characterizations challenges and demonstrate the unmatched capabilities our TLA-based solutions in various projects (e.g. CAR-T, TCR).
Sign up for this webinar to learn more about:
- Current genetic characterization challenges
- Specific Critical Quality Attributes (CQA) requested by FDA and EMA
- Why conventional technologies can be suboptimal when it comes to fully addressing those genetic QC needs
- Capabilities of our TLA-based solutions to assess genetic safety (e.g. integration sites, insert integrity, off-targets, etc.)
The webinar will be concluded with a Q&A.
Your host:
Alexander Jansma, MSc
Sales & Account Manager, Cell & Gene Therapy
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