Platelet Lysate
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Human platelet lysate (or hPL) is a substitute supplement for
fetal bovine serum Fetal bovine serum (FBS) is the most widely used serum-supplement for the ''in vitro'' cell culture of eukaryotic cells. It is commonly utilized in biomedical research, pharmaceutical development, and biomanufacturing due to its ability to suppo ...
(FBS) in experimental and clinical cell culture. It is a turbid, light-yellow liquid that is obtained from human blood
platelets Platelets or thrombocytes () are a part of blood whose function (along with the coagulation factors) is to react to bleeding from blood vessel injury by clumping to form a blood clot. Platelets have no cell nucleus; they are fragments of cyto ...
after freeze/thaw cycle(s). The freeze/thaw cycle causes the platelets to
lyse Lyse may refer to: People * Lyse Doucet (born 1939), Canadian journalist, presenter and correspondent for BBC World Service radio and BBC World television * Lyse Richer (born 1958), Canadian administrator and music teacher * Carl L. Lyse (1899– ...
, releasing a large quantity of growth factors necessary for cell expansion. hPL has the highest concentration of growth factors of any serum supplements. FBS-free cell culture media, e.g. with platelet lysate or chemically defined/ animal component free, are used for
cell therapy Cell therapy (also called cellular therapy, cell transplantation, or cytotherapy) is a therapy in which viable cells are injected, grafted or implanted into a patient in order to effectuate a medicinal effect, for example, by transplanting T- ...
or
regenerative medicine Regenerative medicine deals with the "process of replacing, engineering or regenerating human or animal cells, tissues or organs to restore or establish normal function". This field holds the promise of engineering damaged tissues and organs by st ...
. They are commercially available in GMP (
good manufacturing practice Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutic ...
)-quality which is generally basis for regulatory approval.


Process

Platelets have a life span of 5 to 9 days. Because of this, the
U.S. Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...
(FDA) expires transfuse-able platelets 5 days post-collection. Typically, hPL is produced from expired platelets that have been stored in frozen conditions no later than 7 days post-collection. hPL is created from single or pooled donor-donated platelets isolated from whole blood or by apheresis, distributed in a standard platelet collection bag. There are some differences between hPL manufacturing protocols, but they all share the same core of being frozen at very low temperatures and thawed. This process may be repeated two or three times to cause complete platelet lysis. The resultant hPL can then undergo different manufacturing steps to achieve multiple grades of hPL. The most common form of hPL undergoes few processing steps, producing a product made of the supernatant following the freeze/thaw process. The included clotting factors require to add heparin to the cell culture media to prevent coagulation during incubation. Another form of hPL is one that can be used in cell culture without the need of heparin, or any anticoagulant, addition. This grade of hPL goes through further manufacturing steps to inhibit the effect the clotting factors have. Many labs around the world are creating small amounts of hPL to suit their laboratory needs. The disadvantages of this process are: cost and consistency. When creating small batches of hPL (single or few donors pooled), the lot-to-lot consistency of the hPL becomes variable. Large-scale manufacturing by pooling many platelet donors is a necessity to mitigate the donor-to-donor variability. Consistency is a top priority for experimental designs to provide reproducible results. Platelet lysate is commonly used for supplementation of basal media in
mesenchymal stem cell Mesenchymal stem cells (MSCs), also known as mesenchymal stromal cells or medicinal signaling cells, are multipotent stromal cells that can Cellular differentiation, differentiate into a variety of cell types, including osteoblasts (bone cells), ...
s culture. Prior to use, the pathogen inactivation process is recommended to prevent pathogen transmission.


Global sales

Human platelet lysate is available commercially through AventaCell BioMedical
Elk Bioscience
Mill Creek Life Sciences, Compass Biomedical, Inc., Sexton Biotechnologies, Macopharma SA, iBiologics, PL BioScience GmbH, Life Science Group Ltd (UK) and Trinova Biochem GmbH under the product lines UltraGRO, PLTMax, PLUS, Stemulate, Human Platelet Lysate, XcytePlus, PLSOLUTION, PLMATRIX and CRUX RUFA Media Supplements. Platelet lysate has also been produced with non-human animal material and has been made commercially available by Agulos Biotech (porcine) and Japan Biomedical (bovine). Some companies provide different grades of platelet lysate including GMP versions and clinical grade for use in human clinical trials. Platelet lysate offers a true human-based recombinant protein platform. Platelet lysate has been tested in various
cell culture Cell culture or tissue culture is the process by which cell (biology), cells are grown under controlled conditions, generally outside of their natural environment. After cells of interest have been Cell isolation, isolated from living tissue, ...
applications including use in advanced
bioreactor A bioreactor is any manufactured device or system that supports a biologically active environment. In one case, a bioreactor is a vessel in which a chemical reaction, chemical process is carried out which involves organisms or biochemistry, biochem ...
systems.Platelet lysate consisting of a natural repair proteome supports human mesenchymal stem cell proliferation and chromosomal stability. Cell Transplant Cell Transplant 2011 19;20(6):797-811. Epub 2010 Nov 19. http://www.bioprocessintl.com/manufacturing/cell-therapies/expansion-human-mesenchymal-stem-cells-using-microcarriers-human-platelet-lysate/


See also

* Laboratory use of serum


References

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