Generate Life Sciences Establishes Newborn Stem Cell Manufacturing Plant
The GMP facility is designed to maximize the efficiency of newborn stem cell bioprocessing and large-scale manufacturing.
Generate Life Sciences has announced the establishment of its Good Manufacturing Practices (GMP) facility in La Jolla, Calif., For the end-to-end manufacture of biological stem cell products for newborns. This facility will add the role of a personalized therapy developer with in-house manufacturing capabilities to the company’s core international donor gamete, genetic services and neonatal stem cell preservation businesses.
With its bioreactor system, automation and compliance with cGMP regulations, the new facility is designed to maximize the efficiency of newborn stem cell bioprocessing and large-scale manufacturing.
“The La Jolla GMP facility will be a crucial addition to Generate’s vision for our newborn stem cell operation,” said Jaime Shamonki, medical director of Generate Life Sciences, in a press release. “As the largest private bio-repository of neonatal stem cells in the world, we believe it is our duty to continually invest in new scientific applications for neonatal stem cells with the aim of increasing access to new ones. therapies for families. With this facility, we will have the internal capacity to take these stem cells throughout the process of collecting, cryogenic storage, and ultimately biologics manufacturing. This will allow us to feed our studies in a much more efficient and streamlined manner and will help us better serve the families who have stored over 1.2 million units of stem cells with us. “
Mesenchymal stem cells (MSCs) can be isolated from umbilical cord tissue and used in regenerative medicine due to their anti-inflammatory, immunomodulatory and tissue repair properties. Researchers and scientists are targeting the use of MSCs for the treatment of conditions such as autoimmune diseases, acquired neurological diseases, lung diseases and conditions related to infertility. Additionally, MSCs are used in clinical trials for cell therapy, gene therapy, tissue engineering, and combination products.