The Development of Therapeutic Monoclonal Antibody Products

This report provides a roadmap for the development of a monoclonal antibody product from initial discovery through the filing of an Investigational New Drug Application (IND) or Investigational Medicinal Product Dossier (IMPD) or equivalent for first in human clinical trials. The primary focus of the report is on the technical, regulatory, and management issues related to process development, manufacturing, quality control, and analysis of fulllength single specificity monoclonal antibody products produced in mammalian cell culture. The report provides a detailed analysis of the technical and regulatory requirements necessary to successfully develop therapeutic monoclonal antibody products from discovery through first-in-man clinical trials and also gives an overview of the strategic and regulatory considerations for late-stage development and commercialization of these products, including a detailed discussion of such important issues as process validation, Quality by Design, manufacturing economics, and the risks and benefits associated with the use of platform processes.

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