Generate Life Sciences, the largest private newborn stem cell biorepository in the world, announced the establishment of its Good Manufacturing Practice (GMP) facility in La Jolla, California, to manufacture newborn stem cell biologics. This bolsters the company’s existing stem cell research and repository capabilities with mesenchymal stem cell (MSC) biologics manufacturing.
The new facility, equipped to ensure biological products meet FDA quality standards, has been designed to harness the inherent properties of newborn stem cells to maximise efficiency and manufacture at scale. Newborn stem cells, which include MSCs, can be isolated from umbilical tissue and express a superior expansion capability to their adult counterparts. With their powerful properties, MSCs are being explored for use in regenerative medicine, and are being studied in clinical trials for cell and gene therapy, tissue-engineering, and combination products. Umbilical cord MSCs present therapeutic potential for autoimmune disease, acquired neurological diseases, lung disease, and conditions related to infertility.
“With this facility, we will have the in-house capability to take these stem cells through the complete process of collection, cryogenic storage and ultimately biologics manufacturing. This will allow us to power our studies in a much more efficient and streamlined manner and help us better serve the families who have stored over 1.2 million stem cell units with us,” said Jaime Shamonki, MD, Generate’s Chief Medical Officer
The new La Jolla facility is a step in continuing Generate’s legacy of firsts in the private newborn stem cell banking industry, and pushing the envelope in regenerative science further.
About Generate Life Sciences
Through its range of pioneering brands, Generate has guided almost a million families through reproductive, newborn stem cell, genetic screening, medical device, and healthcare technology services. Headquartered in in Los Angeles, the company operates across the globe.