Due to the Corona outbreak, the conference has been postponed. We are currently awaiting information from ISPE concerning a new date.
Join us at Europe’s most comprehensive event on the latest innovations in pharmaceutical manufacturing,
Leaders representing EMA, EDQM, FDA, MHRA, WHO, and more will provide compelling and thought-provoking perspectives throughout the event, including during the first-ever Plenary Panel Discussion with regulators, as well as the in-depth GMP for the pharmaceutical Industry training course led by two experts from the FDA.
Cell therapy journey from research to clinical manufacturing
Joint presentation by Christina Dragsbaek Ravn, Project Manager at Novo Nordisk and Henriette Schubert, Global Technology Partner, Facilities & Laboratories at NNE
ATMP’s and cell therapies are part of a biopharma revolution and part of the future. Cell and gene therapies are modernizing biopharma and are giving patients new treatment opportunities.
There are a lot of ‘un-knowns’ and rapid development when it comes to both research and clinical manufacturing of ATMPs.
The industry problem and opportunities are:
- ATMPs are different when compared to traditional products and manufacturing. Hence, a different approach is needed for the novel research and transition to clinical manufacturing
- When process development and facility design is overlapping – there’s a high risk of mismatch and the final result may not be optimal. One of the opportunities being detaching the process and equipment from the facility design to ensure maximum flexibility and adaptation in the manufacturing setting
- New ways to conquer the process and equipment adjustments during the facility design and in the construction
- Challenges related to the transition from non-GMP to cGMP manufacturing. The ‘language’ used in R&D differs from the ‘language’ used for manufacturing. These differences calls for special attention during the transition from R&D to manufacture to ensure project success
- ATMP equipment availability and matureness: Process equipment for ATMP manufacturing may have to be initiated using a stand-alone approach that require manual handling until future feasible industrialization of these processes and equipment are available
A case story, based on a cGMP facility for cell therapy, will be presented to highlight challenges and opportunities in the transition from development to clinical manufacturing and include an example of a flexible, adaptable and future-proof facility design concept.