Fujifilm Diosynth Biotechnologies and ContraFect Corporation have announced that they have signed a contract to support the process development and cGMP manufacture of CF-301, ContraFect’s Staphylococcal-specific bacteriophage lysin. CF-301 is ContraFect’s lead compound and displays potent activity against all forms of Staph infections, including methicillin-resistant (MRSA) and vancomycin-resistant strains (VISA/VRSA).
The initial part of the programme will utilise Fujifilm Diosynth Biotechnologies’ pAVEway™ advanced protein expression technology to establish a high productivity process. The pAVEway™ technology is a platform based on a unique set of protein expression plasmids that can incorporate a range of vectors developed by Fujifilm Diosynth Biotechnologies using DNA looping to tightly control protein production at high and reproducible expression levels. The programme will be executed at Fujifilm Diosynth Biotechnologies’ site in Billingham, UK.
Founded in 2008 by Dr Robert Nowinski, who serves today as the company’s chief executive officer and chairman of the board, ContraFect is a biotechnology company pioneering the use of lysins to treat life-threatening infectious diseases. "CF-301 is a protein that differs from antibiotics and is effective against all current and potential drug-resistant Staph infections," remarked Dr Nowinski. "ContraFect has now completed its laboratory research on CF-301 and has moved to pre-clinical development with an eye towards its IND submission in Q2 2012 and our first in man clinical trials later that year."
Fujifilm Diosynth Biotechnologies brings to the development of CF-301 over 25 years of biopharmaceutical contract development and manufacturing experience with over 150 projects, including commercial manufacturing of four licensed products. "We are delighted to be selected by ContraFect for development of CF-301," said Steve Bagshaw, managing director of Fujifilm Diosynth Biotechnologies’ UK business. "By combining the application of our pAVEway™ expression technology with our extensive knowledge and experience, we are well positioned to have a long and successful partnership between our companies. This partnership with ContraFect is very much in line with our goal to be a solutions provider to our clients."
"ContraFect Corporation is very pleased to work with Fujifilm Diosynth Biotechnologies to bring CF-301 through clinical development and to the market," said Dan Couto, ContraFect’s vice president of product development. "Fujifilm Diosynth Biotechnologies’ vast experience with microbial production and large-scale integration mitigates many typical risks in CMC biologics development, thus assuring material supply to our patients for this unmet medical need."