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PDA TR 81-2019

Cell-Based Therapy Control Strategy

This technical paper aims to provide an overview of the approaches and tools available to support the design of a control strategy, considering the current regulatory framework and guidelines and proposing a pragmatic guidance applicable to cell and gene therapy. It highlights an approach for development of early-stage CGTP based on established concepts and describes how this approach can be used to ensure that the control strategy can be successfully managed as the product evolves. To illustrate how specific QbD elements can be applied, this technical report discusses the use of target product profiles, quality target product profiles, critical quality attributes, material attributes, and critical process parameters. It also indicates which risk management tools can be used to identify the attributes related to the product and process, as well as demonstrate the relationships that links the product profile to quality attributes and product attributes to material attributes and process parameters. Potential mitigation strategies are proposed for risks related to process or product and the design of a manufacturing control strategy for a product in early-phase clinical development is illustrated. T he content of this technical report applies to autologous and allogeneic cell therapy applications, including cells with ex vivo genetic modification. Though some concepts may be applicable to their development, gene therapy vectors for in vivo dosing are not within the scope of this report, however. As the focus of this report is early-stage development and due to the complexity of cell and gene therapy products, such topics as design space, process analytical technology, continuous/ongoing process verification, and process robustness are not addressed.

Content Provider
Parenteral Drug Association [pda]

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