期刊
INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES
卷 22, 期 10, 页码 -出版社
MDPI
DOI: 10.3390/ijms22105178
关键词
regeneration; human platelet lysate (HPL); good manufacturing practice (GMP); cell therapy; platelet concentrates; regenerative medicine
资金
- European Union [731377, 733006]
- Land Salzburg/WISS 2025 [20102-F1900731-KZP]
- Land Salzburg [20102-F2001080-FPR]
- Land Salzburg/IWB/EFRE 2014-2020 [P1812596]
- ParacelsusMedical University of Salzburg [R-20/04/137-PLS]
HPL serves as a valuable alternative to fetal bovine serum in cell culture, allowing for efficient and animal serum-free cell propagation. Providers must adhere to strict quality control and regulatory requirements to ensure safe and GMP-compliant production of HPL. The starting material for HPL preparation is fresh or expired platelet concentrates from healthy donors, and the process may involve pathogen reduction technologies.
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.
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