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

Chaya Mazouz, Orgenesis Inc.

Additional Panelists:

Johnny Lam, CBER, FDA

Marcos Timón, AEMPS

Marcos Timon

Appearances