BIOPROTEIN AND Q-ONE BIOTECH SIGN AGREEMENT FOR BIOSAFETY TESTING AND PROCESS VALIDATION OF RECOMBINANT PROTEINS

New collaboration allows BioProtein to provide complete biomanufacturing solutions to its customers

Paris, France and Glasgow, Scotland… BioProtein Technologies, the biotechnology company specialising in the production of therapeutic proteins in the milk of transgenic rabbits, and Q-One Biotech, signed today an agreement regarding biosafety testing and process validation of the recombinant therapeutic proteins produced by BioProtein Technologies. This new agreement ensures BioProtein Technologies’ customers will be provided with the highest standards in biomanufacturing, in terms of safety and quality.

Under the terms of the contract, Q-One Biotech becomes BioProtein Technologies privileged supplier for the biosafety testing and process validation of recombinant proteins produced in the milk of transgenic rabbits, in compliance with North American and European GLP requirements. Q-One Biotech brings a proven expertise in the fields of biosafety testing and contaminant clearance in the production of recombinant proteins and monoclonal antibodies for therapeutic use.

Transgenic rabbit is a very attractive model in terms of scale-up, flexibility, time-to-market and cost, as transgenic rabbits expressing the protein of interest in their milk can be obtained in only one month. Complex proteins such as monoclonal antibodies, plasma proteins and hormones can be rapidly produced in quantities sufficient for clinical studies needs. Also, following successful clinical trials, the production of the recombinant protein can be taken forward to 10 kilograms a year based on the annual production of 400 lactating rabbits. The present deal ensures the safety of the protein synthesised, even though no contaminants transmissible to humans, including prion disease has been detected in rabbit milk so far.

Marc Le Bozec, CEO of BioProtein Technologies said: “This deal with Q-One Biotech shows our commitment to deliver our customers safe and reliable biomanufacturing services.” He added: “Following our agreement with Eurogentec for protein purification last year, this agreement enables us to offer our customers a complete solution for their biomanufacturing needs: from the gene to isolated and purified proteins, in compliance with GMP-standards”.

"We are very happy at Q-One Biotech to collaborate with BioProtein Technologies. For over twelve years, Q-One Biotech has worked with many of the biotechnology industry's most innovative companies. This new collaboration highlights our extensive experience in developing appropriate safety testing strategies for established and novel technologies," says Fiona Godsman, Director of Marketing at Q-One Biotech.

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Notes to the Editors

About BioProtein Technologies
www.bioprotein.com

BioProtein Technologies is the world leader in the production of recombinant proteins in the milk of transgenic rabbits. The Company’s unique contract manufacturing capabilities have been designed to meet the increasing demands of the pharmaceutical and the biotechnology industries for therapeutic protein production. Rabbits offer great advantages in terms of scale-up and time-to-market and can produce up to 10-15 litres of milk per year. From the annual production of 400 rabbits, up to 5-10 kg of protein can be isolated and purified to a very high quality.

BioProtein Technologies has a strong expertise through the entire manufacturing process from genes or cDNA expression to animal production. The Company is using high quality science, for example from INRA, as the foundation for building BioProtein Technologies into a world-leading producer of therapeutic proteins. The Company has produced complex and difficult-to-express proteins, including monoclonal antibodies, plasma proteins, hormones and vaccinating antigens, all of which demonstrates BioProtein Technologies’ ability to fulfil the most rigorous specifications in protein production.

As a corporation, BioProtein Technologies recognizes that it has a specific responsibility towards the animals that it generates and breeds for the production of therapeutic proteins. The Company conducts its animal research and development according to the highest ethical standards.

The Company was founded in 1998 and successfully completed its first € 8 million financial round in May 2001.

About Q-One Biotech
www.q-one.com

Q-One Biotech provides specialist safety testing and process validation services and contract manufacturing to the biopharmaceutical industry. Their services include GLP accredited safety testing of biopharmaceuticals, human blood products, vaccines, transgenics and gene therapy products. Q-One Biotech has devised over 500 study protocols to test cell lines, biological material and final products to fulfil regulatory requirements. They also perform process validation studies for removal/inactivation of viral, DNA, mycoplasma and scrapie/BSE contaminants.

Q-One Biotech’s purpose built facilities are located in Glasgow, Scotland, UK and Worcester, MA, USA and operate in full compliance with GMP and GLP standards. Both facilities operate to the same high standards of service and provide consistency in terms of quality systems, study protocols and technical and regulatory support.