PLTMax® HPL, Gamma Irradiated

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.

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.