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Manufacturing by Design Methodology

Following the success of autologous cell therapies, allogeneic T-cell therapies are moving toward late-stage clinical trials and commercial registration. Catalent is preparing for the commercialization of cell therapies using its custom approach called Manufacturing by Design (MbD) methodology. This method was developed in-house to overcome challenges associated with cell therapy manufacturing. In the biologics industry today, Quality by Design (QbD) methodology is widely implemented by biopharmaceutical manufacturers with an emphasis on product quality as it provides a solid foundation to understand product attributes. QbD, however, presents limitations in addressing process efficiencies which continues to pose challenges in cell therapy scalability. Additionally, QbD is mainly applied to drug substance and less to the drug product.

Catalent’s Cell Therapy team was an early adopter of QbD methodology in the field of T-cell-based therapies and understands the gap areas of this methodology as it relates to addressing scalability and the supply chain complexity of cell therapy manufacturing. By embracing the efficiencies of QbD while innovating within the challenge areas of QbD, the Catalent Cell Therapy team was able to develop a customized approach for addressing manufacturing complexities tied to the production of biological materials. This methodology, Manufacturing by Design, will lead manufacturers toward a path of operational excellence every step of the way from the bench to the clinic.