PolTREG has completed the construction of the second stage of the investment 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, the company reported.
“Currently, construction works in stage I (unit one – research and development laboratory) and stage II (unit two – commercial laboratory) of the investment have been completed. The first production unit was fully equipped, using which the Company produced the first TREG cell preparation compliant with GMP (Good Manufacturing Practice). Final work is currently underway to complete the equipment for the second production unit. Once the work is completed, this stage will be validated, and after the certification of the first unit is completed, the Company will obtain certification of the second unit in the procedure of extending the consent already granted by GIF,” we read in the announcement.
The company is currently in the process of obtaining appropriate decisions and consents, including GMP certification, from the Main Pharmaceutical Inspectorate and the National Center for Tissue and Cell Banking issued for a new manufacturing site in order to produce TREG as an ATMP (advanced therapy investigational medicinal product), it was announced.
Obtaining the appropriate decisions and consents will enable the company to produce its own cell therapies for the purposes of clinical trials and offer 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.
PolTREG estimates that the unique knowledge and experience in the field of cell therapies and the modernly equipped Research and Development Center constitute a complete and unique development platform enabling the signing of a partnership agreement with a pharmaceutical company that intends to use TREG therapies in the treatment of autoimmune diseases.
The new investment will also significantly increase the company’s production capacity. The maximum production capacity of two units will be approx. 1.5 thousand. preparations per year, it was emphasized.
PolTREG is a global pioneer of Treg-based cell therapies – the most advanced in clinical trials. The creators of PolTREG performed the world’s first administration of TREG to a human. The company debuted on the WSE main market in 2021.