BrainStorm Cell Therapeutics, a leading developer of cellular therapies for neurodegenerative diseases, has received Good Manufacturing Practice (GMP) approval.
The approval has been given from the Israel Ministry of Health for three state-of-the-art cleanrooms leased by the company at the Tel Aviv Sourasky Medical Center in Tel Aviv, Israel.
The GMP approval confirms that these cleanrooms are compliant with Israeli GMPs, which are aligned with European Union (EU) GMPs, and more than doubles the company's capacity to manufacture and ship its NurOwn platform into the EU and local Israeli markets.
The hospital hosts newly built state-of-the-art cleanroom suites
"We are proud to be the first company to have been granted GMP certificate at the Sourasky Hospital's Institute for Advanced Cellular Therapies, that hosts newly built state-of-the-art cleanroom suites to advance our proprietary cellular technology platform in ALS and other neurodegenerative diseases," said Chaim Lebovits, CEO of BrainStorm.
"The GMP certification of these additional cleanrooms means that we now have more than doubled the capacity to supply NurOwn to ALS patients across Israel and Europe," Lebovits added. "This is critical, as ALS is a truly debilitating disease and patients are in urgent need of new therapies. We remain committed to addressing this unmet need and continue to discuss our clinical data with leading experts as we assess potentially regulatory pathways for NurOwn in various jurisdictions."
About NurOwn
The NurOwn technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders.
MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo.
MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells are designed to effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilise disease progression.