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

Katharina Schallmoser, Reinhard Henschler, Christian Gabriel, Mickey B.C. Koh, Thierry Burnouf

研究成果: 雜誌貢獻回顧型文獻

1 引文 (Scopus)

摘要

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.

原文英語
期刊Trends in Biotechnology
DOIs
出版狀態已發佈 - 一月 1 2019

指紋

Platelets
Blood Platelets
Inventions
Quality management
Pathogens
Stromal Cells
Biological Products
Blood Transfusion
Intercellular Signaling Peptides and Proteins
Blood
Therapeutics
Innovation
Specifications
Safety
Serum

ASJC Scopus subject areas

  • Biotechnology
  • Bioengineering

引用此文

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. / Schallmoser, Katharina; Henschler, Reinhard; Gabriel, Christian; Koh, Mickey B.C.; Burnouf, Thierry.

於: Trends in Biotechnology, 01.01.2019.

研究成果: 雜誌貢獻回顧型文獻

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