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European Biopharmaceutical Review

Bridging the Gap

Regenerative medicine (the art of repairing or replacing damaged tissues and organs through cellular engineering) has seen remarkable advances in the past decade. Positive clinical trial results, particularly in cancer immunotherapy, have prompted a surge in the number of cell-based therapies progressing toward commercialisation. Apheresis and cell collection centres must quickly adapt to handle the increased demand for cell therapy starting materials. Concerns over upholding quality oversight, particularly for Good Manufacturing Practice (GMP)-qualified starting materials, should also be addressed.

Apheresis collection centres interact closely with both donors and the pharmaceutical companies developing cellular therapies and are, therefore, in an ideal position to devise solutions to these challenges. This article will focus on how apheresis facilities aim to adapt collection centre infrastructure to support higher demand while streamlining downstream processing and ensuring quality oversight. The authors will examine specific quality control challenges posed by cryopreserved GMP products and the related need to adapt and standardise cold chain protocols. Bridging the gap from donor collection to successful therapeutic relies on the ability to collect high-quality starting material and assure that the finest quality and efficacy of the final cell-based product can be achieved.

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Dominic Clarke PhD has over 15 years’ experience developing enabling solutions for cell therapy and bioprocessing applications. Dominic is the Global Head of Cell Therapy at HemaCare, where he is actively engaged with industry experts to ensure the highest quality materials are delivered. Previously, he held roles as the Global Product Manager for Charter Medical’s cell therapy and bioprocessing disposables portfolio, focussed on creating flexible closed-system solutions for early- and late-stage production, and as the Director of Research and Development at BioLife Solutions, developing novel biopreservation media and methods to support extended stability of cells and tissues.

Brad N Taylor PhD is the Senior Product Manager at HemaCare. Brad has over 13 years’ experience in the biotechnology industry, addressing multiple aspects of drug discovery and preclinical development. Previously, he held roles as Application Scientist and Product Manager in the in vivo imaging division of PerkinElmer, where he worked to bring innovative solutions to market to assist the research community in expediting and streamlining the process of preclinical drug discovery for cancer and other clinical applications in animal models of disease.
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Dominic Clarke PhD
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Brad N Taylor PhD
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