The GMP manufacturing process and the facility was developed with $4m grant received from the Hungarian Office for Innovation and Technology.
Genetic Immunity CEO Julianna Lisziewicz said establishment of a GMP manufacturing facility is a major milestone for the company.
"Initially, it will serve our need to produce high quality ingredients to our nanomedicine products tested in clinical trials," Lisziewicz added.
"We developed our GMP manufacturing technology and processes to be suitable to upgrade them to a commercial scale.
"This approval demonstrates the capability of our team to advance our DermaVir HIV-specific immunotherapy to the market, and our new candidate products from the bench to the bedside."
Power of the Dream Ventures CEO Viktor Rozsnyay said with this GMP facility, the company has closed the manufacturing gap between clinical trial scale and the commercial production.
"With continuous development of the manufacturing processes we are able to control the costs and achieve a competitive price for each market segments at an attractive ROI ratio for every product," Rozsnyay added.
"We are strongly focused on the market and are well prepared for large scale manufacturing for our planned Expanded Access program of DermaVir."