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PLTGold Human Platelet Lysate is a growth factor rich, xeno-free, heparin-free cell culture supplement which has undergone gamma irradiation at a dose of 25-38 kGy. Ideal for therapeutic research and clinical trials. FDA Master File available, US origin.
Human Platelet Lysate (HPL) provides superior cell performance and cell expansion when compared to other supplements such as FBS or chemically defined media. PLTGold® HPL is a revolutionary xeno-free, heparin-free supplement which provides rapid cell expansion with proven success across various cell types including MSCs and immune cells. Available in research and clinical grades, PLTGold® is an excellent supplement to cell culture media and for use in both 2D and 3D culture systems with a focus on research and cell therapy applications.
PLTGold Human Platelet Lysate has undergone gamma irradiation at a dose of 25-38 kGy. MCLS validated the gamma process with a 5-virus viral clearance study that demonstrated viral inactivation with each of the viruses.
Applications: Media supplement, cell culture, cell therapy research, drug discovery, MSCs, T Cells, Hematopoietic Stem Cells, and iPSCs
Figure 1. Real time imaging of adipose-derived MSC growth using PLTMax® or PLTGold® Human Platelet Lysate as a media supplement showed increased cell growth kinetics compared to cells grown in medium supplemented with FBS or Human AB Serum.
Figure 2. T cells expanding in media with PLTGold® Human Platelet Lysate.
Figure 3. Performance of PLTGold® vs serum based media. Time-lapse of adipose-derived MSCs from day 0 to day 5 of culture with (left) PLTGold® 5%, (middle) FBS 10%, and (right) Human AB Serum 5%.
Since Human Platelet Lysate is considered a biologic and not a drug, its submission and documentation are now handled by the FDA’s Center for Biologics Evaluation and Research (CBER), who recognizes these submissions with Master File numbers. CBER does not currently publish the Master Files on the FDA’s website.
Drug Master Files (DMF) are recognized by the FDA’s Center of Drug Evaluation and Research (CDER) agency for submissions made regarding the manufacturing, processing, packaging, and storing of human drug products. Master Files (MF) are recognized by the FDA’s Center of Biologic Evaluation and Research (CBER) agency for submissions made regarding the manufacturing, processing, packaging, and storing of human biologics. While there was overlap in regulatory oversight for biologics and drugs, the FDA created two independent specialized centers with premarket review and oversight responsibilities to deal with each product type, given their extremely different composition and manufacturing protocols
Large-scale expansion of cells including MSCs, T-cells, hematopoietic stem cells, iPSCs, tumor cells, and fibroblasts.
Yes, PLTGold is a completely xeno-free supplement that does not require heparin (or used in the manufacturing process). PLTGold has an FDA registered Master File available for reference.
PLTGold is a completely xeno-free human platelet lysate which contains all essential growth factors for healthy cell growth. Donor units are pooled in large batches and manufactured by Mill Creek Life Sciences under a proprietary method to produce highly consistent and reliable lots.
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