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Clinical grade PLTGold® Human Platelet Lysate is 100% xeno-free, heparin-free supplement for use in cGMP clinical applications. Clinical grade PLTGold® products are further certified to be endotoxin free and is great for generating cells in large scale bioreactors. Master File available with the FDA available.
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® is for use in cGMP clinical applications. Clinical grade PLTGold® products are further certified to be endotoxin free.
Cell types: MSCs, T cells, Endothelial cells, NK cells, tumor cells, iPSCs, and more!
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.
Both grades are manufactured under the same conditions and follow the same protocols. The clinical-grade product includes additional endotoxin testing and batch record documentation. All products have a CofA available.
Starting at $25.00
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