Genetic engineering specialist Delphi Genetics announced that it has received the certificate of Good Manufacturing Practice (GMP) for plasmid DNA production. The GMP productions will be realized in clean rooms located in Delphi Genetics’ own facilities. Furthermore, the GMP facilities will benefit from the company's 'Antibiotic Free" Technology.
Following the GMP audit and approval by the Federal Agency for Medicines and Health Products (AFMPS), Delphi Genetics is now allowed to produce plasmid DNA either as clinical batches or commercial batches for companies involved in the development of gene therapy, DNA vaccination or DNA-based therapies.
“This GMP approval represents a significant step forward in the implementation of Delphi Genetics’ new strategic orientation,” commented François Blondel, Chairman of the board of Directors. “It will allow us to accelerate the development of the company as a key player in Europe for bio- production of DNA,” he added.
“This approval ideally paves the way for Delphi Genetics to be the partner of choice for companies involved in the development of gene therapies, DNA vaccines and other therapies using plasmid DNA such as cell therapies or viral vector productions. It allows us to support our customers in the clinical phases of the development of their products,” further added Cédric Szpirer, Founder, and Executive & Scientific Director.
In addition, the GMP productions will benefit from the proprietary and patented “antibiotic free” Staby® technology of Delphi Genetics. This innovative technology allows bio-productions of plasmid DNA and recombinant proteins without the use of antibiotics and antibiotic resistance genes, meeting regulatory agencies expectations. Additionally, Delphi Genetics also achieves higher yields than classic bio-productions while having a perfectly stable and scalable production process.
According to industry experts, the global DNA market will continue to grow at 40+% compound annual growth rate. The DNA vaccination market is expected to reach $2.7 billion by 2020. There are currently about 500 compounds in pre-clinical and clinical development.
More information: http://www.delphigenetics.com