Cell-based Assays: Design, Development, and Validation Intensive: From Concept to Validation - US version
03-04 December, 2024
Bioassay formats and case studies
ONLINE TRAINING | 03-04 December, 2024
Starting time: UTC 13:00 p.m.
Overview
For the release of biotechnological products, potency is a mandatory critical quality attribute that manufacturers must evaluate to ensure it conforms to specifications for releasing drug substance and drug product batches. Cell-based bioassays are commonly used to determine potency. While binding assays, including non-cell-based assays, can be considered during early clinical development, regulatory bodies expect that cell-based bioassays reflecting the mechanism of action of the biotherapeutic be developed and implemented during late clinical development. These assays should then be appropriately validated before performing the process performance qualification. This Master Class addresses common bioassay formats, as well as the development and validation of bioassays.
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As of November 2006, Ive been appointed Vice-President, Head of Biotech Process Sciences at Merck-Serono, based in Vevey, Switzerland, in charge of developing and validating the manufacturing processes for biotechnological products. In that context, whereas Serono was mainly using perfusion processes for recombinant hormones and cytokines, we moved the company to large-scale manufacture of monoclonal antibodies using proprietary chemicallydefined cell culture media and feeds. After our participation to the FDAs pilot program on Quality by Design, the concepts described in ICH Q8(R2) and ICH Q11 were implemented in our approach to gain process understanding. It was concluded by issuing a modernized approach for process validation at Merck (Darmstadt, Germany). More recently, we have introduced advanced processes such as intensified fed-batch and continuous downstream processing.
Who should attend?
-Bioassay development scientists
-Bioassay validation personnel
-Stability scientists
-QA/QC personnel
-Regulatory CMC
-CMC project managers