PolTREG has completed the construction of the Research and Development Center for the development of the TREG method in innovative therapies for autoimmune diseases, the company announced. PolTREG is currently in the process of installing laboratory equipment and obtaining relevant decisions and approvals, including GMP (Good Manufacturing Practice) certification from the Main Pharmaceutical Inspectorate and the National Center for Tissue and Cell Banking. Obtaining the relevant decisions and consents will enable the company to produce its own cell therapies for the purposes of clinical trials and offering therapies under the hospital exception procedure, and will allow it to conduct research and development work on the next generations of innovative therapies for autoimmune diseases.
“The production of cell and gene therapies is complex, which is why the strategic value of our facility is very high for several reasons. Having a modern production plant will enable us to produce our own therapies on a significantly larger scale than before, which, combined with the portfolio of projects in the clinical phase, the company’s unique knowledge and experience in the field of cell therapies, constitute a complete platform for the development of therapies for autoimmune diseases. We believe that these factors will have a positive impact on the process of commercialization of our technology, which, as planned, we will intensify in the coming months,” said Piotr Trzonkowski, CEO, quoted in the release.
Ultimately, the company will have 2,100 m2 of production space and 15 production lines, with a maximum throughput of up to 700 batches of therapy per year, which will significantly increase the current production capacity. The plant is one of the most modern in Europe, it was emphasized.
“At the same time, the second stage of investment in a plant for the production of cell therapies as part of the project ‘Implementation on the market and dissemination in Poland of an innovative method of treating type 1 diabetes by purchasing infrastructure for the cultivation of T-regulatory cells’ co-financed by the Polish Agency for Enterprise Development is in progress” – we read further.
Completion of the investment in the research and development and production laboratory was one of the issue goals of the company’s public offering, which took place in the fourth quarter of 2021.
PolTREG is a global pioneer of Treg-based cell therapies – the most advanced in clinical trials. The creators of PolTREG conducted the world’s first administration of TREG in humans. The company debuted on the main market of the Warsaw Stock Exchange in 2021.