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MONTREAL—Seeking to help distinguish its immunotoxicity competencies from the phage-based biosensor business that is its namesake, Biophage Pharma Inc. recently completed a restructuring of its contract research organization (CRO) business. The restructuring effort is also driven in part by an expected shift in the preclinical drug approval process that will likely significantly boost the need to assess the effects of drug candidates on the immune system.
 
The CRO division is now known as Immunotox Labs, has its own logo and Web site, and will focus on immunogenicity and immunotoxicity work. The new division also offers analytical services, including bioassays validation and efficacy studies, in the fields of infection, inflammation and cancer. The Immunotox Labs division of Biophage Pharma also reportedly operates the only non-government beryllium reference lab in Canada.
 
Biophage has been offering immunotoxicity testing at the preclinical and clinical levels for more than a decade, so the line of business is nothing new. It already had laboratories with state-of-the-art instrumentation and full GLP compliance, notes Miguel Retamal, the director of Immunotox Labs. The scientific staff with its knowledge and expertise was already in place to serve client needs in the areas of antibody engineering, monoclonal and clonal production and characterization. And the division's assays have already long since been validated in different animal models including rodents, dogs and primates.
 
What was missing was people readily associating Biophage with immunogenicity and immunotoxicity.
 
"A lot of people choose to see us just as a phage company," Retamal says. "And that makes sense because of the company name. We started off as a phage company and that is still an important, major aspect of what we do. But we have had to do contract research in order to make profits because R&D can be such a long road."
 
"Now, with our new division focused in immunotoxicology, we will change the perception that we are only a phage company," he adds, "and at the same time, the two parts of the company—immunotoxicity and phage—can focus on their respective work and clients."
 
"At Biophage we are developing a proactive roadmap in order to concentrate on our core competencies and know-how and to increase immunotoxicity market penetration," stated Dr. Rosemonde Mandeville, president and CEO of Biophage, in a news release. "We have been in the forefront in the last 10 years, offering selected methods that have been demonstrated to be adequately sensitive and specific for known immunosuppressive agent evaluation."
 
Retamal says that the company is currently preparing a marketing campaign to substantially increase market share in the immunotoxicity and immunogenicity arenas. "We expanded our core assets and built a strong team that has all the required credentials to carry on routine as well as innovative projects," he says. "We are now strategically focused on the immunotoxicology business."

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