Fujifilm Diosynth Biotechnologies and ContraFect Corporation announced today that they have signed a contract to support the process development and cGMP manufacture of CF-301, ContraFect’s Staphylococcal-specific bacteriophage lysin
MORRISVILLE, N.C.--(BUSINESS WIRE)-- Fujifilm Diosynth Biotechnologies and ContraFect Corporation announced today 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 program will utilize 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 program will be executed at Fujifilm Diosynth Biotechnologies site in Billingham, United Kingdom.
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.”
About Fujifilm Diosynth Biotechnologies
FUJIFILM Diosynth Biotechnologies U.S.A., Inc. is an industry-leading Biologics Contract Development and Manufacturing Organization. Fujifilm Diosynth has extensive experience in the development and manufacturing of recombinant proteins, vaccines, monoclonal antibodies, among other large molecules expressed in a wide array of microbial, mammalian, and insect systems. The company offers a comprehensive list of services from cell line development, including its proprietary pAVEway™ system, to process development, analytical development, clinical and commercial manufacturing. Fujifilm Diosynth Biotechnologies is also located in Billingham, UK as FUJIFILM Diosynth Biotechnologies UK Limited. Both sites have been FDA-approved for the production of commercial products. For more information, please visit: www.fujifilmdiosynth.com.
FUJIFILM Holdings Corporation, Tokyo, Japan, brings continuous innovation and leading-edge products to a broad spectrum of industries, including electronic imaging, digital printing equipment, medical systems, life sciences, graphic arts, flat panel display materials, and office products, based on a vast portfolio of digital, optical, fine chemical and thin film coating technologies. The company was among the top 16 companies around the world granted U.S. patents in 2010, and in the year ended March 31, 2011, had global revenues of $25.8 billion*. Fujifilm is committed to environmental stewardship and good corporate citizenship. For more information, please visit: www.fujifilmholdings.com.
*at an exchange rate of 86 yen to the dollar.
About ContraFect Corporation
ContraFect Corporation is a biotechnology company pioneering the use of monoclonal antibodies and lysins to treat life-threatening infectious diseases. ContraFect's initial products include agents to treat diseases such as MRSA (drug resistant staphylococcus bacteria), other serious bacterial infections, and influenza.
ContraFect’s scientific approach is based on the following principles:
- Monoclonal antibodies for the treatment of life threatening bacterial and viral diseases
- Lysins for the treatment of drug-resistant gram positive bacteria, such as staphylococcus (MRSA), streptococcus and intestinal infections
- Transition from conventional monotherapy to a combinatorial approach using multi-therapy antibody and Lysin treatments
- Address the growing challenge of drug-resistance and therapy escape mechanisms used by pathogens
All product and company names herein may be trademarks of their registered owners.
Fujifilm Diosynth Biotechnologies
Bridget Hall, +44 (0)1642 367320
Anitra B. Johnson, 919-337-4409
Barry Kappel, Ph.D., MBA
VP Business Development
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