Comparability – demonstration of product equivalence after a process change – is recognised by key regulatory stakeholders as particularly difficult for cell based medicinal products.
The meeting discussed a range of circumstances from minor to major changes that require the establishment of comparability and discuss how risk based approaches, manufacturing controls and appropriate comparability protocols can be used to address the issues raised by these change.
The Briefing Paper, Workshop Agenda and contributors presentations are provided here:
- 01 – PSCP Comparability Workshop Introduction
- 02 – Comparability: Regulatory Perspective
- 04a – Comparability and Setting Product Specification Limits
- 04b – Quantification of Variation in Biological Input Materials
- 06a – Approaches to Robust Characterisation data
- 08a – Standards for cell-based medicines
- 12a – A Manufacturing Engineering Perspective
- 12b – Risk-Based Approaches to Comparability
- 14d – Regulatory Considerations for Global Haplobank
- 14e – Manufacturing Control
- 16h – Workshop Summary
Conclusions from this workshop have now been collated and published and are available here.
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