Delphi Genetics and Eurogentec Biologics Collaborate for Antibiotic Resistance-Gene Free GMP Manufacturing
News Nov 17, 2008
Eurogentec SA and Delphi Genetics SA have signed an agreement to co-market the use of StabyDNA technology for GMP manufacturing purposes. The antibiotic resistance-gene free technology, developed and owned by Delphi Genetics allows for clone selection, plasmid stability and manufacturing of plasmids and proteins without the use of antibiotics.
Under the agreement Eurogentec will promote Delphi Genetics’ StabyDNA technology for use in GMP manufacturing on an exclusive basis. The financial terms of the agreement were not disclosed.
Antibiotic markers and antibiotic use in GMP manufacturing is a current point of attention of US and European regulatory agencies. Both agencies recommend moving away from the use of antibiotic resistance genes in the manufacturing process of biotherapeutics, as these resistance genes have no therapeutic value in the final product.
Many plasmid DNA biologics currently going through clinical development contain antibiotic resistance genes; the use of the StabyDNA technology would offer next generation plasmid DNA drugs without antibiotic resistance markers.
Philippe Gabant, CEO at Delphi Genetics said, “This collaboration will strongly contribute to the advancement of the StabyDNA technology for therapeutic applications. Eurogentec has the experience and know-how to manufacture biotherapeutics based on the StabyDNA technology and importantly has biotherapeutic manufacturing experience for all clinical phases.”
Florence Xhonneux, Biologics Business Development Manager at Eurogentec said, “ We are pleased to be collaborating with Delphi Genetics, the StabyDNA technology offers benefits in terms of GMP manufacturing and FDA and EMEA concerns about the use of antibiotics, offering real value to future sponsors of plasmid DNA clinical trials”.