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PLTMax® Human Platelet Lysate, clinical grade is for use in cGMP clinical applications and further certified to be endotoxin free. PLTMax is manufactured to meet the needs of research and development to ensure an easy transition to clinical manufacturing.
PLTMax® Human Platelet Lysate is a growth factor-rich supplement that is a superior alternative to fetal bovine serum (FBS) for cell culture, including human mesenchymal stem cell (MSC) culture. PLTMax® has a proven track record of clinical use. It has been used to grow cells that have been used in hundreds of patients around the world. PLTMax® is used as a manufacturing component in the generation of adult stems cells in clinical trials in North America, Europe, South America, Middle East, Asia and Australia (Phase I to Phase III) in indications including neurology, nephrology, gastrointestinal disease, wound repair and cardiology.
PLTMax® Human Platelet Lysate is derived from normal human donor platelets collected at U.S. blood centers. Multiple donors units are pooled in large batch sizes and manufactured to produce a consistent product.
Addition of an anti-coagulant, such as heparin, is required to inhibit coagulation in media supplemented with PLTMax®. Add heparin to a final concentration of 2 U/mL when preparing complete medium.
Figure 1. Minimal batch variation is seen by real-time imaging of adipose-derived MSCs across five production lots of PLTMax® Human Platelet Lysate. The growth of cells cultured in media from each lot of PLTMax® is plotted based on cell density measured at regular culture timepoints. The difference in cell culture media performance can be seen as early as 36 hours in culture.
Figure 2. 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.
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
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.
Yes, with HPL it is possible to add too much to your cultures. We’ve seen that HPL can slow the growth of MSCs at high concentrations.
Cells grown in human platelet lysate typically use half the concentration compared to cells cultured in fetal bovine serum. Standard protocols suggest adding 5% concentration. However, we recommend titrating anywhere between 2-10% in order to maximize cell growth and narrow in on the best concentration for your cultures.
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