Research such as the Cell and Gene Therapy Catapult's GMP manufacturing report continues to paint a picture of an industry that is growing in size and capability.
As the industry moves towards commercial realisation, there are a number of areas in which companies must focus, including:
- Preparing for a successful audit
- Quality control
- Data handling
The theme for this years workshop is practical considerations for commercial realisation. The objective is to challenge delegates to think carefully about the about the commercial product, market and process from the outset when developing a cell or gene therapy.
Following the workshop delegates should be able to use this information to inform their process development and manufacturing strategy for clinical trials and routine manufacturing.
Highlights from the UK manufacturing survey and future predictions for the industry
Stephen Ward, Cell and Gene Therapy Catapult
Preparing for a successful audit
Liz Allanson, ExPharmaceutical Inspectors Consortium Ltd
MHRA hot topic roundtables: data integrity
Kasia Averall, Cell and Gene Therapy Catapult
Skills, training and the advanced therapies apprenticeship scheme
Validating disinfection regimes
Daria Popova, Cell and Gene Therapy Catapult
Why move to a grade C background?
Seb Hodgkin, Cell Medica
Gene therapy manufacturing
Tim Hillyer, Freeline Therapeutics
Stephen Shapka, Cell and Gene Therapy Catapult
John Churchill, Cell and Gene Therapy Catapult
AAV next-generation quality control
Tony Bou Kheir, Cell and Gene Therapy Catapult