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 two-day 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

Agenda day 1

12:00-12:30 Registration and lunch
12:30-12:40

Welcome

Julie Kerby, Director of Industrialisation, CGT Catapult

12:40 - 13:00

Industry update and future predictions

Dr Stephen Ward, Chief Manufacturing Officer, CGT Catapult

13:00 - 13:30

Preparing for a successful audit

Liz Allanson, ExPharmaceutical Inspectors Consortium

13:30 - 14:40

Data integrity

Kasia Averal, Head of Quality Assurance, CGT Catapult

14:40 - 15:00 Coffee break
15:00 - 15:30

Developing a waste management strategy

Dr Daria Popova, Lead Technical Scientist, CGT Catapult

15:30 - 15:45

Skills and training

Dr Kate Barclay, Consultant

15:45 - 16:15

Why move to a Grade C background?

Seb Hodgkin, VP Quality, Cell Medica

16:15 - 16:40

Automation

Dr Stephen Shapka, Process Development Automation Engineer, CGT Catapult

16:40 - 17:15

PLENARY: Allo PSC based immunotherapy

Dr Pete Mitchell, Group Leader, Adaptimmune

 

Agenda day 2

08:30 - 09:00 Registration and breakfast
09:00 - 09:10

Recap of day one

Julie Kerby, Director of Industrialisation, CGT Catapult

09:10 - 09:40

PLENARY: Affordability and Innovative Reimbursement Models for Commercial Success 

Omar Ali, Visiting Lecturer Value Based Pricing University of Portsmouth & Former Adviser to NICE

09:40 - 10:50

Quality control 

TBC

10:50 - 11:15

Scheduling materials

Nick Page, Chief Operating Officer, Oxford Biomedica

11:15 - 11:35 Coffee break
11:35 - 12:00

In-line technology

Dr John Churchwell, Senior Scientist - Industrialisation, CGT Catapult

12:00 - 12:25

Data handling

Dr Markus Gershater, Chief Scientific Officer, Synthace

12:25 - 12:50

Next-generation products

Dr Edward Samuel, VP Manufacturing, Achillies Therapeutics

12:50 - 13:50 Lunch
13:50 - 14:15

Viral vector manufacturing

Dr Fernanda Masri, Technology Expert for Regenerative Medicine, Sartorius Stedim

14:15 - 14:40

AAV next-generation quality control

Dr Tony Bou Kheir, Senior Analytical Development Scientist, CGT Catapult

14:40 - 15:05

Gene therapy manufacturing

Tim Hillyer, Director of GMP Operations, Freeline Therapeutics

15:05 - 15:25 Coffee break
15:25 - 15:50

Downstream processing 

Dr Quentin Bazot, Viral Vector Scientist, CGT Catapult

15:50 - 16:15

CRISPR

TBC

16:15 - 16:30 Wrap up and close

 

Register here

  • RT : Atelerix Consortium Awarded £267,000 Innovate UK Grant for collaboration with the Cell and Gene Therapy Catapult an… https://t.co/78puK3LzW6 2 hours 7 min ago

Discover who we are