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The Cell and Gene Therapy Products (CGTP) Symposium: Manufacturing, Quality and Regulatory Considerations enables the exchange of scientific ideas and dialogue with regulators that form the basis of evolving regulatory practices in the development of these diverse and innovative products…
Decentralized manufacturing involves the use of manufacturing units that can be deployed to multiple locations and in cases, to sites close to the patients. This new manufacturing concept can bring benefits over more traditional, central manufacturing, allowing, for instance, a production adaptable to demand or a more agile and flexible reaction to public health emergencies. In the case of cell and gene therapies, many are highly personalized or have very short shelf-lives, features that could benefit from being manufactured close to the patients.
Decentralized manufacturing presents new regulatory challenges since it requires a shift away from existing frameworks that are designed to meet the regulatory expectations for large-scale centralized manufacture.
This session will bring together regulators and manufacturers with the objective of reviewing the different decentralized manufacturing approaches (e.g. distributed vs point of care) and identify some of the regulatory adaptations needed. The session will also discuss proposals to fulfil manufacturing and control challenges on a decentralized scenario, such as comparability between (potentially) many manufacturing sites, or carrying out complex testing (e.g. potency).
Session Speakers:
Decentralised and Point of Care Manufacturing - A UK Perspective
Ian Rees, Retired, MHRA
Distributed Manufacturing for Cell Therapies: Regulatory Challenges and Solutions
Gülbengü Yüksel, Tigen Pharma SA
Attaining Worldwide Standardization Within A Decentralized Framework
Allogeneic cell therapies have a potential to revolutionize life-saving Cell and Gene therapy (CGT) field by removing the bottlenecks created by long scheduling delays, lengthy manufacturing times and potential product failures of autologous cell therapies…
Bringing treatment to those afflicted with an ultra-rare disease is complex. These products are encumbered with challenges ranging from high development costs with a limited ROI, to issues with executing and interpreting clinical trials with unusually small patient populations…