Cell and Gene Therapy Manufacturing Workshop - Practical considerations for commercial realisation

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.

Register here

Sample agenda

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
Kate Barclay

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

Automation
Stephen Shapka, Cell and Gene Therapy Catapult

In-line technology
John Churchill, Cell and Gene Therapy Catapult

AAV next-generation quality control
Tony Bou Kheir, Cell and Gene Therapy Catapult

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