Brainstorm Cell Therapeutics Inc (NASDAQ: BCLI), the developer for autologous adult stem cell therapeutics, is known for debilitating neurodegenerative diseases. Yesterday, the leading developer announced that the Israel Ministry of Health granted it Good Manufacturing Practice approval for its second production site. GMP is granted to the company for state-of-the-art cleanrooms in Tel Aviv, Israel. The company has leased the cleanrooms at Sourasky Hospital, or Tel Aviv Sourasky Medical Center.
So what?
The GMP approval is a testimony that the company’s cleanrooms stand in line with the country’s GMPs, which are compliant with GMPs of the European Union (EU). This GMP approval allows double capacity for the company to manufacture and ship its NurOwn®s in the local Israeli market and European Union market. At the same time, the company has now become the first one to be granted GMP at Institute for Advanced Cellular Therapies in Sourasky Hospital. The certification calls for the company to increase its production and supply for NurOwn to the ALS patients with twice the capacity. As a result, the company shall now be serving in Israel and Europe with increased capacity.
This is an essential development since ALS is a debilitating disease with patients needing urgent care for new therapies. The company addresses such patients’ needs and said that it shall continue to work with leading experts regarding its clinical data.
About NurOwn® technology platform
The new tech platform for MSC-NTF cells is the investigational therapeutic approach that targets pathways of diseases, which is extremely important in the case of neurodegenerative disorders. Mesenchymal stem cells (MSCs) derived from bone marrow are the source of MSC-NTF cells. MSCs are then converted to MSC-NTF cells. Autologous MSC-NTF cells deliver multitudes of NTFs or immunomodulatory cytokines effectively and directly into the damage site, so elicit the required biological effect. This can ultimately stabilize and slow the progression of the disease.
