TY - JOUR
T1 - Production and Quality Requirements of Human Platelet Lysate
T2 - A Position Statement from the Working Party on Cellular Therapies of the International Society of Blood Transfusion
AU - Schallmoser, Katharina
AU - Henschler, Reinhard
AU - Gabriel, Christian
AU - Koh, Mickey B.C.
AU - Burnouf, Thierry
N1 - Publisher Copyright:
© 2019 Elsevier Ltd
PY - 2020/1/1
Y1 - 2020/1/1
N2 - 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.
AB - 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.
KW - cell propagation
KW - cell therapy
KW - human platelet lysate
KW - mesenchymal stromal cells
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U2 - 10.1016/j.tibtech.2019.06.002
DO - 10.1016/j.tibtech.2019.06.002
M3 - Review article
AN - SCOPUS:85069001611
SN - 0167-7799
VL - 38
SP - 13
EP - 23
JO - Trends in Biotechnology
JF - Trends in Biotechnology
IS - 1
ER -