Requirement for smart in-process control systems to deliver cell therapy processes fit for the 21st century

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Damian Marshall, Stephen Ward & Marc-Olivier Baradez

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The cell therapy field continues to experience significant growth with an increasing number of therapies approaching commercialization and over 535 products currently undergoing phase II and III clinical trials [1]. This focus towards commercialization is leading cell therapy innovators to increasingly look at technologies which can support improved product monitoring, allow more controlled processing and increased consistency during manufacturing. These needs are similar to those experienced in conventional bioprocessing where approaches such as quality by design (QbD) are increasingly being applied to achieve enhanced control of therapeutic products such as monoclonal antibodies. QbD incorporates prior product knowledge with the use of statistically designed experiments, risk analysis and knowledge management. The intent of QbD is to develop sufficient understanding of the product to ensure robustness and consistency in the manufacture process. As the cell therapy field continues to mature it is timely to look at how learnings and technologies from related fields can be used to expedite the development of modern cell therapy manufacturing strategies.

DOI: 10.18609/cgti.2016.074
Citation: Cell Gene Therapy Insights 2016;2(6),683-689.

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