A new cell therapy which will help people with serious conditions such as Crohn’s disease will be manufactured at the QIMR Berghofer Medical Research Institute.
NeuroScientific Biopharmaceuticals has announced a transfer of its patented manufacturing process for its mesenchymal stromal cells to QIMR Berghofer’s Q-Gen Cell Therapeutics (Q-Gen).
NeuroScientific CEO Nathan Smith said the company’s subsidiary, Isopogen, had previously signed a contract with QIMR Berghofer, for Q-Gen to undertake manufacturing process development, scale-up and clinical grade manufacture of their StemSmartTM platform technology.
“Q-Gen, located within QIMR Berghofer in Brisbane, is one of the largest cell therapy contract manufacturers in Australia, with 13 cleanrooms dedicated to cell manufacturing and quality control,” Mr Smith said.
He said Q-Gen specialised in manufacturing cellular immunotherapies for clinical trials, both national and international.
“Q-Gen, which holds a TGA licence for cell therapy manufacture and has more than 25 years in cell therapy manufacturing for industry, has the experience, expertise and capacity to manufacture StemSmartTM.”
Mr Smith said the commencement of the technology transfer to Q-Gen was an important milestone for the Company to establish its cell manufacturing and enable it to undertake further clinical trials and pursue commercial opportunities.
“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.”
QIMR Berghofer COO Dr Stephen Weller said Q-Gen’s commitment to advancing cell therapies meant a long-term partnership with Isopogen by bringing their StemSmartTM technology to the clinic to improve the lives of chronically ill patients.
Dr Weller said the StemSmartTM technology would facilitate the manufacturing of human allogeneic mesenchymal stromal cells that had shown efficacy in serious clinical conditions such as Crohn’s disease and graft versus host disease.
“QIMR Berghofer is delighted that NeuroScientific Biopharmaceuticals has selected the Q-Gen Cell Therapeutics facility to manufacture their GMP cell therapy.”
