Amgen, Genentech, Abbott, Medlmmune, GSK, Lilly, and Pfizer will create examples of development programs that follow ICH quidelines for product registration.

Conformia has brought together seven pharmaceutical and biotech firms to provide a series of examples that will assist others in interpreting and using ICH quality guidelines for product registration. Amgen, Genentech, Abbott, Medlmmune (now part of AstraZeneca), GlaxoSmithKine, Eli Lilly, and Pfizer make up the Chemistry Manufacturing and Controls (CMC) Biotech Working Group.

The seven companies will ally to create a fictitious but realistic example of a mAb whose development program embraces the ICH quality vision. ICH, or the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, consists of European, Japanese, and U.S. regulatory authorities and industry experts. They recommend ways to achieve to reduce or obviate the need to duplicate testing carried out during R&D for registration purposes.

Results from the group will be released in Spring 2009. “The output of the CMC Biotech Working Group will not only be available for the industry but also for regulators across the globe who seek to better understand how the concepts of the ICH quality vision might be applied in day-to-day practice inside firms,” remarks Anjali Kataria, founder of Conformia.

“This will provide significant business benefits to the industry,” adds Kenneth B. Seamon, Institute of Biotechnology, University of Cambridge and cofacilitator of the CMC Biotech Working Group, “as well as facilitate a more innovative and comprehensive approach for national authorities to review and assure the quality of biopharmaceuticals.”

This collaboration is part of Conformia’s CRADA partnership with FDA to identify how the ICH’s principles can be applied in pharmaceutical development. It builds on the company’s experience in developing a case study for pharmaceuticals, called ACE, and the resultant formation of the CMC-IM Working Group in 2007.

Conformia reports that findings from a pilot study indicated a significant unmet need in the availability of examples for biotech product/process development. Furthermore, according to ICH, the top 30 companies, by fully implementing the ICH guidelines, stand to save a total of $8 billion a year.

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