Press Release Source: Eurogentec
Thursday November 13, 6:21 am ET
GMP plasmid manufacturer and plasmid platform technology supplier team up for new biotherapeutic offering
LIEGE, Belgium -- 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, with lower cost of goods and in higher quality.
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”.
About Delphi Genetics SA
Founded in 2001, Delphi Genetics focuses on developing new, much more effective products and technologies for gene cloning and protein expression in bacteria. The products and services developed by Delphi Genetics are based on unique technologies using bacterial poison-antidote genes. Delphi Genetics’ patented Staby® technology improves the efficiency of protein expression and allows successful production of recombinant proteins that had been impossible produce with standard methods. Moreover, the Staby® technology allows producing proteins and plasmid DNA without the use of antibiotics. For more information please visit http://www.delphigenetics.com
About Eurogentec SA
Founded in 1987, Eurogentec offers products and services to researchers in the Life Science, Diagnostic and Therapeutic fields throughout Europe, Asia and the Americas. The Biologics business unit produces GMP material for phase I, II and III clinical trials and is expecting an FDA audit in 2009 for commercial manufacturing. With over 400 GMP batches produced of over 70 different drug substances, Eurogentec’s biologics unit is a leader in the production of proteins, plasmids and vaccines from microbial sources. For more information please visit http://biologics.eurogentec.com.
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Contact:
Delphi Genetics SA
Daniel Stieber (PhD)
dstieber@delphigenetics.com
Tel: +32-71-378-525
or
Eurogentec SA
Pascal Bolon
p.bolon@eurogentec.com
Tel: +32-4-366-6116
Source: Eurogentec