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Review

Human Platelet Lysate for Good Manufacturing Practice-Compliant Cell Production

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Department of Transfusion Medicine, Paracelsus Medical University of Salzburg, 5020 Salzburg, Austria
2
Spinal Cord Injury and Tissue Regeneration Center Salzburg, Paracelsus Medical University of Salzburg, 5020 Salzburg, Austria
3
Cell Therapy Institute, Paracelsus Medical University of Salzburg, 5020 Salzburg, Austria
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GMP Laboratory, Paracelsus Medical University of Salzburg, 5020 Salzburg, Austria
*
Author to whom correspondence should be addressed.
Academic Editor: Wilhelm K. Aicher
Int. J. Mol. Sci. 2021, 22(10), 5178; https://doi.org/10.3390/ijms22105178
Received: 20 April 2021 / Revised: 7 May 2021 / Accepted: 11 May 2021 / Published: 13 May 2021
Numerous cell-based therapeutics are currently being tested in clinical trials. Human platelet lysate (HPL) is a valuable alternative to fetal bovine serum as a cell culture medium supplement for a variety of different cell types. HPL as a raw material permits animal serum-free cell propagation with highly efficient stimulation of cell proliferation, enabling humanized manufacturing of cell therapeutics within a reasonable timeframe. Providers of HPL have to consider dedicated quality issues regarding identity, purity, potency, traceability and safety. Release criteria have to be defined, characterizing the suitability of HPL batches for the support of a specific cell culture. Fresh or expired platelet concentrates from healthy blood donors are the starting material for HPL preparation, according to regulatory requirements. Pooling of individual platelet lysate units into one HPL batch can balance donor variation with regard to essential platelet-derived growth factors and cytokines. The increasingly applied pathogen reduction technologies will further increase HPL safety. In this review article, aspects and regulatory requirements of whole blood donation and details of human platelet lysate manufacturing are presented. International guidelines for raw materials are discussed, and defined quality controls, as well as release criteria for safe and GMP-compliant HPL production, are summarized. View Full-Text
Keywords: regeneration; human platelet lysate (HPL); good manufacturing practice (GMP); cell therapy; platelet concentrates; regenerative medicine regeneration; human platelet lysate (HPL); good manufacturing practice (GMP); cell therapy; platelet concentrates; regenerative medicine
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MDPI and ACS Style

Oeller, M.; Laner-Plamberger, S.; Krisch, L.; Rohde, E.; Strunk, D.; Schallmoser, K. Human Platelet Lysate for Good Manufacturing Practice-Compliant Cell Production. Int. J. Mol. Sci. 2021, 22, 5178. https://doi.org/10.3390/ijms22105178

AMA Style

Oeller M, Laner-Plamberger S, Krisch L, Rohde E, Strunk D, Schallmoser K. Human Platelet Lysate for Good Manufacturing Practice-Compliant Cell Production. International Journal of Molecular Sciences. 2021; 22(10):5178. https://doi.org/10.3390/ijms22105178

Chicago/Turabian Style

Oeller, Michaela, Sandra Laner-Plamberger, Linda Krisch, Eva Rohde, Dirk Strunk, and Katharina Schallmoser. 2021. "Human Platelet Lysate for Good Manufacturing Practice-Compliant Cell Production" International Journal of Molecular Sciences 22, no. 10: 5178. https://doi.org/10.3390/ijms22105178

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