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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.
New advancements in clinically safe and effective human platelet lysate T cell culture supplements advance CAR-T therapy applications.
Both grades are manufactured under the same conditions and following the same protocols. The Clinical grade material is subjected to more robust release testing and batch record documentation as indicated by the information provided on the certificate of analysis (ex: endotoxin testing).
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.
This Research Spotlight highlights the use of gamma irradiated PLTMax and PLTGold, showing improved safety profile, cell yield, and cellular phenotype in comparison to other products available in the market.
