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Posted: April 4, 2009
Genetic Immunity Licenses Large-Scale Purification Process for Plasmid-DNA Manufacturing
(Nanowerk News) Power of the Dream Ventures, Inc., Hungary's premier technology acquisition and development company, is pleased to present this Genetic Immunity release, based on a previously announced agreement whereby Power of the Dream Ventures will issue communications for Genetic Immunity on a going forward basis.
Genetic Immunity is pleased to announce the licensing of a large-scale purification process for pharmaceutical grade plasmid-DNA manufacturing from Aldevron LLC, a US based contract manufacturing organization that specializes in purifying plasmid-DNA and other biological molecules.
"We have been working with the Aldevron team for a year now to develop technology suitable for manufacturing large plasmid DNA ( > 10kb). One of the limitations we encountered in trying to use current DNA manufacturing technologies was that current suppliers have optimized their technology for much smaller plasmid DNA manufacturing. These processes are not suitable for manufacturing the required quantity and quality of large plasmid DNAs we need. The Active Pharmaceutical Ingredients in our products are large plasmid DNAs expressing simultaneously many antigens. For example, the DNA in our DermaVir Patch investigational HIV vaccine is almost 12kB. It has been very challenging to obtain from contract manufacturers acceptable quantity and quality of this size plasmid DNA," commented Julianna Lisziewicz, CEO of the Company.
"We are very excited to be working with Genetic Immunity and helping them meet their quality and production requirements in support of phase II clinical trials and beyond. We view all of our work with clients as collaborative efforts and this collaboration with Genetic Immunity has resulted in several interesting manufacturing innovations," added Justin Poley, Business Development Director Aldevron LLC.
"We are very happy to have acquired a license to this technology from Aldevron because it is optimized to our plasmid DNA needs. Of equal importance is the fact that the quality of the DNA produced is suitable for our patented nanoformulation technology. Once our manufacturing facilities are established in Budapest we plan on becoming the largest producer of plasmid-DNA in Central-Eastern Europe. This will not only allow us to meet our own needs, but to supply the best quality products to other companies and researchers working in this field. Our facility will also allow us to meet stringent quality control and volume needs as we move forward with several clinical trials, and the eventual treatment of patients. Genetic immunity is not just a cutting edge Research and Development Company, our vision is to produce the products needed for our protocols and treatments," commented Zsolt Lisziewicz, COO of the Company.
Plasmids are closed circular molecules of double-stranded DNA that range in size from 1 to > 20 kB. Plasmids often contain genes that code for antigens and enzymes that can be advantageous to the host cell in some circumstances. The encoded proteins may be involved in inducing immune responses, resistance to, or production of antibiotics, resistance to toxins. Genetic Immunity proprietary DermaVir Patch technology uses special, 12kB plasmid-DNA, encoding most of the HIV genetic information. The plasmid is formulated to a nanomedicine and delivered to the dendritic cells of the lymph nodes to induce potent immune responses.