Business
BioRestorative Therapies Announces cGMP Cell Manufacturing Facility Certification
Certification Gives BioRestorative Therapies Clinical Grade Manufacturing Capabilities MELVILLE, N.Y., April 04, 2022 (GLOBE NEWSWIRE) -- BioRestorative
About this update from Biorestorative Therapies, Inc.
[{"type":"text","content":"Certification Gives BioRestorative Therapies Clinical Grade Manufacturing Capabilities MELVILLE, N.Y., April 04, 2022 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (the “Company” or “BioRestorative”) (NASDAQ: BRTX), a clinical stage company focused on stem cell-based therapies, today announced that it has completed testing and certification of its clinical grade cell therapy manufacturing facility. The cGMP manufacturing facility is a three suite ISO 7 certified clean room environment. The facility will support BioRestorative’s clinical manufacturing needs for its active Phase 2 clinical trial targeting chronic lumbar disc disease. BioRestorative’s Phase 2 trial is a double-blind controlled, randomized study to evaluate the safety and preliminary efficacy of a single dose intradiscal injection of BRTX-100, its lead cell therapy candidate. A total of up to 99 eligible patients will be randomized across 15 clinical sites in the United States to receive either the investigational drug (BRTX-100) or control. It is anticipated that the first patient will be treated during the second quarter of 2022. “Possessing the capability to produce clinical grade therapeutics in-house provides us with valuable quality control and oversight in connection with our Phase 2 clinical trial manufacturing process. The importance of ensuring that BRTX-100 is produced under the defined standards of quality and release criteria cannot be overly emphasized”, said Lance Alstodt, the Company’s CEO. In addition to supporting the manufacturing needs for the BRTX-100 Phase 2 trial, BioRestorative’s facility will also provide clinical production of the Company’s pipeline of clinical and investigational cell therapy candidates. The new facility provides cGMP manufacturing according to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) regulations and guidelines to support clinical grade cell production. About BioRestorative Therapies, Inc. BioRestorative Therapies, Inc. (www.biorestorative.com) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. Our two core programs, as described below, relate to the treatment of disc/spine disease and metabolic disorders: • Disc/Spine Program (brtxDISC™): Our lead cell therapy candidate, BRTX-100, is a product formulated from autologous (or a per...