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Development of a Biopharmaceutical is…Complex

By: Sheila G. Magil, Julia Adam, Dawn Ecker, and Susan Dana Jones
Reprinted with the permission of Pharmaceutical Processing, October 2012

Developing a biopharmaceutical is just like developing a traditional small molecule therapeutic…except it is not. While the types of data needed for regulatory filings is the same, the significantly increased size and molecular complexity of biopharmaceuticals compared to small molecule therapeutics has a significant impact on the strategies and activities required for development. Biopharmaceuticals can consist of proteins or other types of products such as peptides, nucleic acids, viral gene therapy vectors, carbohydrates, and lipids, alone or in combination. The majority of biopharmaceuticals on the market today are proteins, and therefore this article focuses on those activities required primarily for development of protein-based therapeutics.