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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
Cell and Gene Therapy programs are progressing from early academic settings to commercial manufacturing at increasingly faster pace and in greater numbers. These therapies are complex, difficult to manufacture in large quantities, and involve many bespoke technologies to make, test and release…