Use of excipients to control aggregation in peptide and protein formulations

  • Edward Maggio Aegis Therapeutics


Aggregation is rapidly emerging as a key issue underlying multiple deleterious effects for peptide or protein-based therapeutics, including loss of efficacy, altered pharmacokinetics, reduced stability or product shelf life, and induction of unwanted immunogenicity. In addition, bioavailability and pharmacokinetics of a self-associating peptide can be influenced by aggregate size and the ease of disruption of the non-covalent intermolecular interactions at the subcutaneous site. This review highlights the various types of aggregates encountered in peptide and protein formulation, methods useful in detecting aggregates, and recent developments in the use of excipients to prevent or reduce peptide and protein aggregation.

Author Biography

Edward Maggio, Aegis Therapeutics
Edward T. Maggio, Ph.D., Chief Executive Officer and Director. Prior to co-founding Aegis, Dr. Maggio was founder and Chief Executive Officer of Structural Bioinformatics Inc., subsequently renamed Cengent Therapeutics. He was founder and Chief Executive Officer of ImmunoPharmaceutics, Inc. (IPI), which developed a number of endothelin antagonists, including Pfizer’s (formerly Encysive Pharmaceuticals') Thelin® (Sitaxsentan), approved in 2006 for sale in Europe for cardiovascular disease and currently in US clinical trials. Dr. Maggio has been a founder and board member of seven public and private life science companies in the San Diego area and one in Copenhagen, Denmark. He received his Ph.D. from the University of Michigan and was an NIH postdoctoral fellow at the University of California, San Francisco (UCSF) Department of Pharmaceutical Chemistry. He is a member of the Advisory Board of the Polytechnic Institute of New York University, Department of Chemical and Biological Sciences; and serves on the University of California, San Diego Dean's Board of Advisors for Biological Sciences; the California State University, San Marcos, Biotechnology Programs Advisory Board; and the Industry Council of the San Diego Consortium for Regenerative Medicine. Dr. Maggio has edited and coauthored a number of books and scientific articles in the biotechnology area and is an author of more than three-dozen issued and pending U.S. and foreign patents.
How to Cite
MAGGIO, Edward. Use of excipients to control aggregation in peptide and protein formulations. Journal of Excipients and Food Chemicals, [S.l.], v. 1, n. 2, p. 40-49, sep. 2010. ISSN 21502668. Available at: <>. Date accessed: 03 oct. 2022.