Pre-Conference Workshop Day - Tuesday 25th May
9.00 – 11.00 BST
Building Best in Practice Control Strategies of CGT Products
- The attribute criticality of ATMP products are still in the early understanding phase faced by the very complex and multiple MoA combined with limited process and product knowledge.
- The complexity of ATPMs is mirrored by complex manufacturing processes (multifarious biological and technological processes), accompanied by intensive and sophisticated testing /control strategy, particularly the potency assay(s) and demand with new regulatory strategies. The importance of the CMC is highlighted by the application refusal of the CMC chapters (e.g. comparability, impurities and potency).
- Together in this workshop we are developing a common understanding of a potential adequate control strategy covering content, identity, safety, purity and potency of the final ATMP product
Workshop Leader: Roland Pach, Analytical Team Lead, Roche
Christina Grigoriadou, Senior Scientist, AstraZeneca
11.30 – 1.30 BST
The ‘What, Why & How’ for Reference Standards: Your Ultimate Guide
- What are the different types of reference standards and what are their uses?
- When do I need a product reference standard and how and when are these changed?
- How should in-house reference materials be tested and controlled?
- Dossier requirements for approval
Workshop Leader: Christopher Bravery, Consulting Regulatory Scientist, Consulting on Advanced Biologics
2.00 – 4.00 BST
Seeking Higher Throughput & Smaller Scale Analytical Techniques
- Working with complicated assays and aiming for faster timelines
- What role can platform assays play in aiming to adhere to shorter timelines?
- Introducing automation and greater productivity for more CMC compliant methods
- Changing mindsets from the classical mythology to new advancements to the analytics field
- Regulatory agency guidelines on the use of new technologiesncy assays and exploring optimised validation timing
Workshop Leader: George Bou-Assaf, Analytical Development Team Leader, Biogen
Ian Anderson, Associate Director Analytical Sciences, Allergan
Tomasz Witkos, Bioassay Scientist, AstraZeneca