GMP‑Grade Human Platelet Lysate - a Game Changer in Stem Cell Therapy

Good Manufacturing Practice (GMP) is a set of regulated and stringent standards, regulating manufacturing processes for human use. When applied to human platelet lysate (hPL), GMP ensures a sterile manufacturing process with real-time documentation and traceable raw materials. This is significant in stem cell therapy because quality affects the safety, reproducibility and clinical outcomes.

GMP-grade hPL is prepared in controlled environments using validated processes such as gamma irradiation, checking for sterility, and assessing the presence of growth factors. This oversight reduces the possibility of contamination and batch to batch variability, two critically significant factors when producing cells for transplantation into patients. For those researchers using GMP hPL, they have the confidence that each cell culture is treated to the same/consistent exposure to a defined set of essential cytokines and other growth factors, thereby ensuring predictable behaviour.

The perhaps most important benefit is regulatory readiness. Clinical trials rely on materials that are GMP compliant. By using GMP hPL, laboratories can drop a large translational barrier. This gets rid of a large barrier between bench and bedside, where timelines to develop may be quicker, and where chances of success in clinical trials may be more favorable.

While a GMP-grade hPL may not replace traditional methods of working with stem cells, it does make stem cell work safer, more reliable and more ready for the future of therapeutic development.