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CMC Biopharma To Work on MAb for Morphotek

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Morphotek, Inc., a U.S. subsidiary of Eisai has entered into agreement with CMC Biopharmaceuticals of Copenhagen, Denmark for development, GMP manufacturing and regulatory documentation support of MORAb-028, a therapeutic antibody targeting advanced melanoma and other cancers. MORAb-028 is a human IgM monoclonal antibody that specifically recognizes a cell surface antigen over-expressed on a significant fraction of metastatic melanoma, brain cancers and non-small cell lung carcinoma.

“We are extremely pleased to have selected CMC as our contract manufacturer for this IgM monoclonal antibody,” said Philip Sass, Ph.D., executive vice president and chief operating officer of Morphotek. “CMC has production and scaleup experience with IgM monoclonal antibodies and a team of dedicated scientists that have tackled difficult purification and analytical development programs. We are confident that CMC will meet both our production and quality goals as well as timelines for product supply to support our planned clinical trials.”

According to Morphotek, its antibody development technologies and expertise have enabled it to successfully develop this unique IgM antibody and establish a process for large-scale production. Historically, IgM MAbs have been underrepresented in human therapeutic development due to production difficulties and other manufacturing constraints. MORAb-028 is being prepared to enter clinical evaluation in 2008.

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