2015
DOI: 10.2217/rme.14.65
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Manufacturing, Characterization and Control of Cell-Based Medicinal Products: Challenging Paradigms Toward Commercial Use

Abstract: During the past decade, a large number of cell-based medicinal products have been tested in clinical trials for the treatment of various diseases and tissue defects. However, licensed products and those approaching marketing authorization are still few. One major area of challenge is the manufacturing and quality development of these complex products, for which significant manipulation of cells might be required. While the paradigms of quality, safety and efficacy must apply also to these innovative products, … Show more

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Cited by 43 publications
(41 citation statements)
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“…Such process changes include a media component change, a donor/starting material change, a manufacturing platform change and the introduction of a new manufacturing site. A recent publication by current and former members and experts of the Committee for Advanced Therapies, EMA has emphasized that demonstrating comparability maybe “difficult for cell-based medicinal products” [3]. …”
mentioning
confidence: 99%
“…Such process changes include a media component change, a donor/starting material change, a manufacturing platform change and the introduction of a new manufacturing site. A recent publication by current and former members and experts of the Committee for Advanced Therapies, EMA has emphasized that demonstrating comparability maybe “difficult for cell-based medicinal products” [3]. …”
mentioning
confidence: 99%
“…Indeed, it will be extraordinarily challenging to perform reductionist mechanistic experiments in human subjects that will conclusively define substantive MOA of MSC-like cells in vivo and meet modern standards of ethical conduct in clinical trials. Nonetheless, all attempts should be made to develop potency measurements that reflect the product’s relevant biological properties and that can also serve as a measure of comparability between production lots [5]. Therefore, defining hypothesis-driven MOA based on correlative in vitro experiments and buttressed, where feasible, with comparative biology approach in animal systems will inform the choice of potency assays to be developed.…”
Section: International Regulatory Authority Guidance On Potency Testsmentioning
confidence: 99%
“…All the above-mentioned steps are time-consuming, laborious, and costly 3 . In addition, all in vitro processing of cells intended for patient transplantation are highly regulated and requires well-trained and accredited personnel and laboratories 4 .…”
Section: Introductionmentioning
confidence: 99%