Design, Development and Validation of Cell-based Bioassays MasterClass - EU edition
03-04 December, 2024
Development and validation of bioassays
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.
03-04 December, 2024, Virtual
Time Zone: UTC/GMT+1 /CET
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.
RECOMMENDATION
Who should attend?
Bioassay development scientists
Bioassay validation personnel
Stability scientists
QA/QC personnel
Regulatory CMC
CMC project managers
Testimonial
Our success stories
"High attention to detail in course content and very well delivered"
Simon Halsey
Product Development Manager
Essentra Packaging
United Kingdom
Our success stories
"Very good training led by two knowledgeable and open experts. Excellent insight given on many complex topics. Interactive and highly useful"
Aurelie Vivicorsi
USP PD Team Manager
Celonic AG
Switzerland
Our success stories
"Great course, impressed with the knowledge of the trainers and ability to answer wide variety of questions!"
Emilia Szwej
Manager, Senior Investigator
MT Sword Laboratories (BMS)
Germany
About GLC
Global Leadership Conferences began as an ambitious dream by three founders ten years ago. Today its an international series of interactive events, exploring the hottest topics in critical fields. Each year, thousands of professionals join us to challenge the status quo and learn innovative ways to create new solutions in Finance, Pharmaceutical, HR, Health & Safety, and Energy.
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