The companies entered a partnership in 2020 to provide CGMP clinical supply of NurOwn, an autologous cellular therapy, developed by BrainStorm
BrainStorm Cell Therapeutics, a developer of cellular therapies for neurodegenerative diseases, and Catalent, a provider of development, launch and supply services for biopharma, cell, gene and consumer health partners, have announced the technology transfer for NurOwn manufacturing at Catalent’s facility has been finalised. NurOwn is an autologous cellular therapy, developed by BrainStorm for the treatment of amyotrophic lateral sclerosis (ALS), progressive multiple sclerosis (PMS) and other neurodegenerative diseases.
The companies entered a partnership in 2020 to provide CGMP clinical supply of the therapy, in anticipation of the product candidate’s potential regulatory approval. It will be manufactured at Catalent’s 32,000 sqft cell therapy manufacturing facility in Houston, Texas.
“The successful completion of this technology transfer with Catalent is an important step in establishing manufacturing preparedness for NurOwn,” said Chaim Lebovits, CEO, Brainstorm Cell Therapeutics. “The manufacturing of cellular therapies such as NurOwn is complex, and requires careful planning and very specific expertise. We are very pleased with the progress we have made with our partner Catalent, which has industry-leading capabilities in this area.”
Manja Boerman, PhD, President, Catalent Cell & Gene Therapy, said: “Our extensive experience in cell therapy development and scale-up was key to the completion of this technology transfer to our state-of-the-art cell therapy facility in Houston, Texas. We look forward to continuing our partnership with BrainStorm and are committed to enabling the advancement of their autologous stem cell therapy product candidate toward a potential future commercial launch.”