The plant, equipped with 2D/3D bioreactors, will enhance its existing stem cell research and repository capabilities with mesenchymal stem cell (MSC) biologics manufacturing, said the company. The site will allow it to add the role of therapeutics developer with in-house manufacturing capabilities to its core international donor gamete, genetics service and newborn stem cell preservation business, it added.
The facility will be fully operational by the end of this year and will primarily serve Generate's North American activities, said a representative.
Meeting the regenerative medicine demand
Newborn stem cells, which include MSCs, can be isolated from the tissue of the umbilical cord, and have a superior expansion capability compared to their adult-sourced counterparts, said Generate. The new facility has been designed to harness these inherent properties to maximize bioprocessing efficiency and manufacture at scale, said the company.
MSCs, which have numerous emerging clinical uses in regenerative medicine, given their potent anti-inflammatory, immune-modulating, and tissue reparative properties, are being utilized in an increasing number of clinical trials for cell therapy, gene therapy, tissue-engineering, and combination products, noted Generate.
The clinical investigational cellular therapies derived from umbilical cord MSCs are targeting conditions such as autoimmune disease, acquired neurological diseases, lung disease, and conditions related to infertility, it added.
Jaime Shamonki, Generate's CMO, said: "As the largest private newborn stem cell biorepository in the world, we believe it is our duty to continually invest in new scientific applications for newborn stem cells with the goal to increase access to novel therapies for families. 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."
Cell banks
June saw Generate also acquire three stem cell banks — Cell Care, Insception, and Cells for Life — in Australia and Canada, thereby extending its global reach.
That deal, it said, expanded the operational footprint of the company across three countries, alongside its distribution network for frozen donor gametes in more than 40 countries. “In particular, it further increases access to newborn stem cell preservation and genetic screening services across North America.”