Oct 9 2012
Genetic Immunity is pleased to announce the GMP approval of its manufacturing facility. The development of the GMP manufacturing process and the facility was financed from a $4 million grant received from the Hungarian Office for Innovation and Technology.
"To establish a GMP manufacturing facility is a major milestone for Genetic Immunity. Initially, it will serve our need to produce high quality ingredients to our nanomedicine products tested in clinical trials. 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," said Dr. Julianna Lisziewicz, CEO of Genetic Immunity.
The GMP status is provided for the manufacturing and the validated quality control processes of the Active Pharmaceutical Ingredient of our immunotherapeutic nanomedicine products. Genetic Immunity has a state of the art R&D laboratory that includes a dedicated GMP facility. Due to the platform feature of our plasmid DNA based nanomedicine technology, only the nucleotide sequence of the DNA is specific for the target disease. Consequently, the manufacturing and the quality control process of the lead and all pipeline products is the same. This means that the GMP facility can be used for the manufacturing all products of Genetic Immunity regardless of clinical stage. The common GMP manufacturing technology simplifies the regulatory process, saves costs and time in clinical development, and reduces time to market approval of medicinal products.
"With this GMP facility we have successfully 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. We are strongly focused on the market and are well prepared for large scale manufacturing for our planned Expanded Access program of DermaVir," said Mr. Viktor Rozsnyay, CEO of Power of the Dream Ventures.
Source: http://www.geneticimmunity.com