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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.
Gamma irradiated human platelet lysate offers unprecedented safety considerations and quality cell yields for clinical applications. This article reviews the importance of using a high quality, reliable human platelet lysate.
It’s never too early to plan the transition from research to clinical grade reagents, especially with human platelet lysate. This guide provides tips for moving your research from RUO to GMP supplements.
A Superior Supplement Over the last several years, human platelet lysate (HPL) has emerged as a superior alternative to fetal bovine serum (FBS) for cell therapy and regenerative medicine applications. As a growth factor-rich, xeno-free media supplement, HPL enables the rapid cell growth and expansion of various types of cells including MSCs and T-cells.
