Elk Bioscience makes clinical-grade pooled human platelet lysate, a xeno-free cell-culture supplement for research, regenerative medicine and cell-therapy manufacturing. Based at the Pennsylvania Biotechnology Center in Doylestown, the company produces its hPL in a proprietary GMP facility using platelet units that would otherwise have been discarded, pooling material from more than 200 U.S. donors to reduce lot-to-lot variation. Its products are GMP compliant, heparin-free and supported by an FDA Data Master File for clinical-trial use.
GMP Compliant
Compliance program
FDA Data Master File Available
Registration
GMP
Quality certification