GMP Certification for Plasmid DNA Bioproduction
Delphi Genetics receives GMP certification for plasmid DNA bioproduction
The GMP production will benefit from the 'Antibiotic Free Technology'
Gosselies - Charleroi, Belgium - 11 July 2017
Delphi Genetics, a company specialized in genetic engineering, is very pleased to announce that it has just 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.
Following the GMP audit and approval by AFMPS, the strict Federal Agency for Medicines and Health Products, Delphi Genetics will be 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+% CAGR. 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.
Cédric Szpirer, Executive & Scientific Director
Tel.: +32 71 25 10 00
Ann Van Gysel - Turnstone Communications
Tel.: +32 475 33 66 00
About Delphi Genetics
Founded in 2001 and located in Gosselies, south of Brussels - Belgium, Delphi Genetics collaborates on projects at all stages of development from R&D to clinical phase. It develops innovative technologies and provides services for pDNA and protein productions, including antibodies, by using its unique expertise in the field of stabilization systems.
Delphi Genetics’ patented “antibiotic-free” Staby® technology increases the yield of recombinant protein or plasmid DNA production in E. coli compared to the traditional approach with antibiotics. The technology has been licensed to several companies active in the food or pharmaceutical industry including Sanofi-Pasteur, GSK Vaccines and Merck-MSD. Delphi Genetics also provides customized services in genetic engineering in E. coli and mammalian cells (CHO, etc.), protein & DNA productions, and antibody development.
More info: www.delphigenetics.com
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