Closure analysis of a mock autologous cell therapy process

Cell therapy manufacturing comprises several open and manual operations, which increase the risk of contamination. To address this risk, BioPhorum’s Cell & Gene Therapy Commercialization Workstream has generated a ‘mock’ process detailing the manufacture of a generic autologous CAR-T product operated through a series of process steps combining open and closed system elements.

The process has undergone an end-to-end closure analysis to identify the operations that pose the highest contamination risks and to provide suggested mitigation solutions to minimize such risks. This paper details the full process and summarizes potential risks and possible mitigations.

The primary aim is to demonstrate the systematic application of a closure analysis method on an ex vivo gene therapy process so that organizations can apply similar analyses to their own processes. The secondary aim is to propose process closure solutions that companies could implement in their own operations.

The methodology will benefit cell therapy engineers when designing a process by systematically evaluating each unit operation and classifying the level of closure. This approach means they can design or improve a cell therapy manufacturing process and reduce the risk of contamination from open processes.

Using this analysis, a controlled, closed, end-to-end cell therapy manufacturing process can be developed to produce a safe drug product with a low risk of process contamination.

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Closure analysis of a mock autologous cell therapy process December 2021.pdf
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