Improved genetic QC for viral vector and ATMP manufacturing
Recorded Thursday 7 April 2022
As the cell & gene therapy (CGT) market continues to grow at a rapid pace, manufacturers are constantly looking for high quality analytical tools. Whether to develop a streamlined, robust GMP-compliant manufacturing processes to consistently deliver high-quality products or simply to present solid evidence towards satisfying the increasingly stringent requirements (issued by the FDA and/or EMA), there is a clear surge in demand for improved genetic analyses of viral vector and ATMP manufacturing.
In this webinar, we will present our robust proprietary genetic QC platform with a multitude of capabilities, uniquely designed to meet the growing demands for advanced genetic quality control assays. Importantly, assays that can help you meet the CGT Chemistry, Manufacturing and Control (CMC) requirements for IND applications. Specifically, with regards to product testing on the levels of identity, purity and potency.
The following topics will be covered:
- Complying with genetic QC requirements mandated by the FDA and EMA
- capture all (genetic) Critical Quality Attributes (CQA) characteristics in a single experiment to address genetic safety and potency
- Case studies demonstrating our genetic QC solutions:
- Vector-producing cell line: FDA/NIH (2020), GSK (2020)
- Immunotherapy product characterization: Memorial Sloan Kettering Cancer Center (2017), Cellectis (2019)