PolTREG S.A., a clinical-stage biotechnology company developing cellular therapies for a range of autoimmune diseases, today announces it has received CGMP certification from Poland’s Chief Pharmaceutical Inspectorate.
This allows it to produce cellular therapies (Advanced Therapy Medicinal Products – ATMP) at its own site.
The certification also enables it to seek permission from Poland’s Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) to perform clinical trials in the facility, for diseases such as Type-1 Diabetes (T1D) and Multiple Sclerosis (MS).
PolTREG was the first company in the world to administer T-reg therapies to patients. Its manufacturing facility is one of Europe’s largest, with over 2,100 m2 of laboratory space, including 15 production lines.
The company has the option to substantially expand the facility to accommodate manufacturing of next-generation engineered therapies and cell therapies from future partners.
“This certification is an important recognition of PolTREG’s capabilities in manufacturing cellular therapies, a highly sophisticated process that requires significant experience to master,” said Prof. Piotr Trzonkowski, CEO of PolTREG, “From our brand new facilities, ship live cells anywhere in Europe within 24 hours. This is a significant potential expansion in treatment options for patients, and an important consideration as our pipeline of Treg cell therapies comes closer to market.”