Human platelet lysate current standards and future developments

Abstract

A state‐of‐the‐art workshop focused on the use of human platelet lysate (HPL) for cell therapy. The meeting established that HPL is used mainly as an adjunct material for ex vivo expansion of mesenchymal stem/progenitor cells (MSCs), where it is successfully used as a substitute for fetal bovine serum. HPL manufacturing as a cell expansion supplement is currently not yet uniformly standardized with regard to platelet source and production methodology. There are very few reports of HPL preparations manufactured specifically for direct clinical use. There exists an urgent need for controlled clinical studies for HPL and for standardization of product definition. Workshop participants also stated a need for consensus minimum release criteria to allow for better product definition and to limit variability in performance. The increasing use of cell‐based therapies including MSCs has led to an increasing demand for HPL, either produced in blood establishments or large‐scale manufacture by biopharmaceutical companies. The use of pooled donor platelets for HPL production may require the implementation of pathogen inactivation procedures and/or removal steps to improve the safety of advanced cell therapy products. There should also be a requirement for thorough risk assessments and risk mitigation steps, including the qualification of suppliers and identification of ingredients as well as meticulous monitoring of product quality and safety profiles. State‐of‐the‐art regulatory approaches for HPL used for human cell propagation and PRP in direct clinical applications were reviewed.

Zika virus infection studies with CD34+ hematopoietic and megakaryocyte‐erythroid progenitors, red blood cells and platelets

“…This is in agreement with three cases, reporting probable ZIKV transfusion‐transmissions via PCs . Of note, since our data showed stability of infectious particles in the plasma fraction, the use of fresh frozen plasma as well as platelet lysates containing plasma must be considered as a potential source of ZIKV transmission . Importantly, our data also suggest that vRNA detection does not always mean the presence of infectious particles and does not necessarily imply a risk for ZIKV transmission.…”

“…23,24 Of note, since our data showed stability of infectious particles in the plasma fraction, the use of fresh frozen plasma as well as platelet lysates containing plasma must be considered as a potential source of ZIKV transmission. 99 Importantly, our data also suggest that vRNA detection does not always mean the presence of infectious particles and does not necessarily imply a risk for ZIKV transmission. This is in line with a previous study, stating that a platelet transfusion received from a donor with detectable levels of ZIKV RNA in plasma and RBCs fraction did not result in infection of the recipient.…”

Systematic Comparison of the Effect of Four Clinical-Grade Platelet Rich Hemoderivatives on Osteoblast Behaviour

“…Another alternative recently proposed is the incorporation of human platelet lysate (HPL) as clinical-grade supplement for cell expansion and cell therapy [19,20]. The biological effect relies on the high concentration of growth factors released from platelets by sequential freeze/thaw cycles.…”

<p>Extracellular Vesicles As Nanomedicine: Hopes And Hurdles In Clinical Translation</p>

“…37 However, unless a strictly chemically defined medium, free of animal or human material, is used, one obvious potential source of possible pathogen contamination is fetal bovine serum (FBS) or human platelet lysate (HPL) supplements. [41][42][43] For this reason, it appears mandatory that EV manufacturers and regulatory authorities scrutinize, through careful risk assessment, these supplements to ensure a sufficient margin of virus safety. In the case of HPL, for which no species barriers for viral transmission exist "vis à vis" expanded human cells or human EV recipients, important complementary safety measures include (a) epidemiological surveillance of the population at national and regional levels, (b) screening procedures of blood donors, (c) testing of donations, and (d) implementation of dedicated pathogen/virus-reduction procedures on starting platelet concentrates and/or during production.…”