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BioProcess Technology Consultants Publishes Report on Development of Therapeutic Monoclonal Antibody Products

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BioProcess Technology Consultants, Inc. announces publication of The Development of Therapeutic Monoclonal Antibody Products, a 334-page comprehensive review and analysis of the Chemistry, Manufacturing, and Control (CMC) activities and regulatory requirements for the development of monoclonal antibody products, from initial discovery, through First-In-Human clinical trials.

The report, by BioProcess Technology Consultants, and produced with critical input and review by GE Healthcare, also includes information on late-stage development and commercialization of these important biologic products and presents strategies for accelerating their development while minimizing risks and costs.

“Drawing on our extensive knowledge of all aspects of monoclonal antibody development and manufacture, this report offers essential strategic advice to senior executives and program managers on the critical issues associated with monoclonal antibody development and also provides a valuable technical and regulatory roadmap for the critical CMC activities required to bring these products to market,” said BioProcess Technology Consultants president and founder Howard L. Levine, Ph.D.

“At a time of increasing attention on monoclonal antibodies as a class of therapeutic products, we provide decision makers with in-depth analysis and recommendations for early stage product development, including detailed information on cell culture and purification process development, manufacturing, quality control, and analysis of full-length single-specificity monoclonal antibody products and the current regulatory requirements for these products.”

Dr. Gunter Jagschies, Senior Director, BioTechnologies R&D, GE Healthcare, said: “In addition to the technical and regulatory requirements for monoclonal antibody product development, the report also discusses manufacturing economics from the production of early stage clinical trial material through large-scale commercial manufacturing. Senior management will find the analysis of manufacturing costs useful in evaluating manufacturing options and strategies, minimizing the cost of manufacturing mature products, analyzing production demand and financial priorities, and implementing technical options for performance improvement.”