Wednesday 3rd December, 2025 – Post-Conference Workshops - GMT (Greenwich Mean Time, GMTZ)
This interactive workshop will run from 9am – 4:30pm.
Technology transfer, the transfer of a manufacturing capability between two sites, is one of the most common but challenging requirement facing the biopharmaceutical industry. In the case of cell and gene therapies, this is exacerbated by the complexity of the technology and its relative novelty.
This course aims to provide a robust foundation for tech transfer execution as well as exploring specific difficulties faced by participants. To this end, the general principles and main challenges of tech transfer will be covered in the morning session. In the afternoon, participants will choose one or several of these key challenges and work on them in small groups. The conclusions will be shared in a plenary, recapitulation session. Example topics include : changes and scale up, establishing comparability, how to apply risk assessments, transferring analytical methods, communicating effectively…
Participants are encouraged to bring their thoughts and experience as well as their live cases (to be share in a non confidential manner)
- Thomas Chattaway - Senior Life Science Consultant, Independent
This interactive workshop will run from 9am – 4:30pm
Through a series of presentations, case studies, interactive discussion and exercises this workshop will delve deeply into the underlying science of developing potency assays.
Some of the topics to be discussed include:
- Overview of what potency is, and what it is not
- Considerations when qualifying and validating bioassays
- From initial ideas, through characterisation to the final potency method
- Clinical correlation
- Regulator objections and why
- Examples of potency assays for approved products
- Examples of a cell and gene therapy potency assays for various product types
Note: The case studies of real potency assays will delve deeply into the underlying science for each product discussed in order to understand why the approach was taken.
- Christopher Bravery, Ph.D. - Consulting Regulatory Scientist, Advbiols
- Thomas Chattaway - Senior Life Science Consultant, Independent
- Christopher Bravery, Ph.D. - Consulting Regulatory Scientist, Advbiols
- Thomas Chattaway - Senior Life Science Consultant, Independent
- Christopher Bravery, Ph.D. - Consulting Regulatory Scientist, Advbiols
- Thomas Chattaway - Senior Life Science Consultant, Independent
- Christopher Bravery, Ph.D. - Consulting Regulatory Scientist, Advbiols