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Discovering manufacturing strategies for successful ATMP development
6 March 2024
UCL researchers met with ATMP specialists from eXmoor pharma, the cell and gene therapy contract development and manufacturing organisation (CDMO), to explore the early R&D considerations, how this can impact product success and the need to understand the commercial endgame.
Photo 1: Clare Blue, Drew Hope, both Senior Translation Consultant at eXmoor, and Laura Murray, Business Development at eXmoor, visited UCL to conduct a workshop on Manufacturing Strategies for Successful ATMP Development for UCL research communities specialising in cell and gene therapy.
The workshop garnered an overwhelming response from over 30 participants. It brought together ATMP experts from eXmoor, the UCL Translational Research Office, and UCL scientists to delve into manufacturing strategies for successful ATMP development.
Clare Blue, Senior Translation Consultant, eXmoor, presented on the early R&D considerations and how this can impact product success - e.g. vector/plasmid design, serotype selection, linking with CDP, CDMO /process selection, key analytical considerations (esp. potency and dosing assays), comparability / material requirements for CMC.
Drew Hope, Senior Translation Consultant, eXmoor, discussed the need to understand the commercial endgame to ensure the FTIH/Phase I product and process are on the same trajectory and not tangential. He highlighted the importance of the first CTA submission and the benefits of having a comparability plan between phase I and the commercial product.
The workshop was followed by 1:1 consultation sessions, allowing UCL researchers to discuss project-specific questions with eXmoor’s senior ATMP specialists, address their project pain points and gain a deeper insight into the pathway from early considerations to therapeutic product success. Topics covered include:
- How to maximise the chances of the product succeeding in clinical trials?
- What are the considerations for Quality Control for a first clinical trial?
- What are the considerations for GMP compliance when it comes to clinical manufacturing?
- What are the steps to take to get to the clinic? How long will it take? How much will it cost?, etc
The event was opened by Dr. Pamela Tranter, TRO’s Head of the Translational Research Group with an introduction to the support by the Translational Research Office, fostering collaborations within and beyond UCL to help UCL biomedical researchers advance the translational research pathway.
We are grateful for the support from all the speakers and contributors to the event, including:
- Clare Blue, Senior Translation Consultant, eXmoor Pharma
- Drew Hope, Senior Translation Consultant, eXmoor Pharma
- Laura Murray, Business Development, eXmoor Pharma
- Dr Pamela Tranter, Head of Translational Research Group, Translational Research Office, UCL
- Dr Nour Al Abdullah Al Kafri, Research Networks and Partnerships Manager, Translational Research Office, UCL
Useful links:
- Support from the UCL Translational Research Office for UCL researchers in developing translational strategies
- About eXmoor
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