Schallmoser, K; Henschler, R; Gabriel, C; Koh, MBC; Burnouf, T
(2020)
Production and Quality Requirements of Human Platelet Lysate: A Position Statement from the Working Party on Cellular Therapies of the International Society of Blood Transfusion.
Trends Biotechnol, 38 (1).
pp. 13-23.
ISSN 1879-3096
https://doi.org/10.1016/j.tibtech.2019.06.002
SGUL Authors: Koh, Mickey
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Abstract
Human platelet lysate (HPL), rich in growth factors, is an efficient alternative supplement to fetal bovine serum (FBS) for ex vivo propagation of stromal cell-based medicinal products. Since 2014, HPL has been a focus of the Working Party for Cellular Therapies of the International Society of Blood Transfusion (ISBT). Currently, as several Good Manufacturing Practice (GMP)-compliant manufacturing protocols exist, an international consensus defining the optimal modes of industrial production, product specification, pathogen safety, and release criteria of this ancillary material (AM) is needed. This opinion article by the ISBT Working Party summarizes the current knowledge on HPL production and proposes recommendations on manufacturing and quality management in line with current technological innovations and regulations of biological products and advanced therapy medicinal products.
| Item Type: | Article | ||||||||
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| Additional Information: | © 2019. This manuscript version is made available under the CC-BY-NC-ND 4.0 license http://creativecommons.org/licenses/by-nc-nd/4.0/ | ||||||||
| Keywords: | cell propagation, cell therapy, human platelet lysate, mesenchymal stromal cells, Biotechnology, 06 Biological Sciences, 09 Engineering, 10 Technology | ||||||||
| SGUL Research Institute / Research Centre: | Academic Structure > Institute of Medical & Biomedical Education (IMBE) Academic Structure > Institute of Medical & Biomedical Education (IMBE) > Centre for Clinical Education (INMECE ) |
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| Journal or Publication Title: | Trends Biotechnol | ||||||||
| ISSN: | 1879-3096 | ||||||||
| Language: | eng | ||||||||
| Dates: |
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| Publisher License: | Creative Commons: Attribution-Noncommercial-No Derivative Works 4.0 | ||||||||
| PubMed ID: | 31326128 | ||||||||
| Web of Science ID: | WOS:000503376700005 | ||||||||
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| URI: | https://openaccess.sgul.ac.uk/id/eprint/112057 | ||||||||
| Publisher's version: | https://doi.org/10.1016/j.tibtech.2019.06.002 |
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