NeuroScientific Biopharmaceuticals Ltd (ASX: NSB) has commenced the transfer of its patented cell manufacturing process to Q-Gen Cell Therapeutics, a move the company says is a key step in advancing its clinical development and commercialisation plans.
The process transfer involves NeuroScientific’s proprietary StemSmart technology, which uses human allogeneic mesenchymal stromal cells and has shown therapeutic promise in treating conditions such as Crohn’s disease and graft versus host disease.
Manufacturing responsibilities are being transitioned from Cell and Tissue Therapy WA at Royal Perth Hospital to Q-Gen, a specialist cell therapy manufacturer based at the QIMR Berghofer Medical Research Institute in Brisbane, as revealed in a news release.
NeuroScientific’s wholly owned subsidiary, Isopogen Australia Opco Pty Ltd, had earlier signed a manufacturing agreement with QIMR Berghofer to support the development, scale-up, and clinical-grade production of StemSmart.
Q-Gen, which operates one of Australia’s largest cell therapy manufacturing facilities, includes 13 cleanrooms dedicated to production and quality control.
“We are very pleased to be partnering with Q-Gen given their extensive experience in manufacturing, process development and GMP production of biologic products for clinical trials. This relationship will allow the Company to scale the manufacturing of its StemSmartTM technology to address substantial market opportunities,” explained NeuroScientific CEO Nathan Smith.
The Brisbane-based Q-Gen facility holds a TGA licence for the manufacture of cell therapies and brings over 25 years of experience in the field.
The facility supports both national and international clinical trials and specialises in manufacturing cellular immunotherapies.
QIMR Berghofer’s Chief Operating Officer, Dr Stephen Weller, welcomed the new partnership. “QIMR Berghofer is delighted that NeuroScientific Biopharmaceuticals has selected the Q-Gen Cell Therapeutics facility to manufacture their GMP cell therapy,” Dr Weller said.
“Q-Gen’s commitment to advancing cell therapies means we look forward to a long-term partnership with the Isopogen team and bringing their StemSmart™ technology to the clinic to improve the lives of chronically ill patients.”
The content of this article is based on information supplied by NeuroScientific Biopharmaceuticals Ltd. For more information, please refer to the official company announcement and communications from NeuroScientific Biopharmaceuticals. Please consult a licensed and/or registered professional in this area before making any decisions based on the content of this article.
