The growth of therapeutic proteins as candidates in drug development pipelines is progressing at a record speed, outpacing significantly small-molecule drug development. Development of commercial protein drugs has been hampered by a variety of sources for instability, particularly the high tendency of protein molecules to aggregate under a wide range of processing and storage conditions. Aggregation of Therapeutic Proteins provides pharmaceutical scientists with a much-needed overview of the causes, consequences, characterization, and control of the aggregation of therapeutic proteins.

Aggregation of Therapeutic Proteins summarizes current understanding and recent progress regarding protein aggregation in the context of biopharmaceutical products. The text:

• Explains methods to control or slow down the aggregation process—a major challenge for pharmaceutical and biotech companies

• Helps readers understand and apply principles to more rapid and predictable commercialization of protein drugs

• Explains and compares analytical methodologies for monitoring and/or characterizing protein aggregation in research and commercial development

• Covers control, inhibition, and monitoring of aggregation during processing, expression and purification, and product formulation

• Includes case studies with more detailed discussions to complement the more general presentations in previous chapters

The text concludes with a discussion of the state of the science as well as key outstanding questions regarding immunogenicity issues for therapeutic proteins and protein aggregates, along with an overview of the regulatory process and considerations in developing protein drugs, with a focus on protein aggregation and stability issues.

No text on the subject can pretend to be comprehensive, but this thorough, authoritative examination will facilitate and stimulate new and continued investigations into the principles of protein aggregation and the application of those principles to more rapid and predictable commercialization of protein drugs and effective protection of human lives in the future.