Chief Scientific Officer, Legacy BioDesign LLC
Challenges and Opportunities in the Formulation of Peptide Therapeutics
In many ways, peptides can be more challenging to formulate than globular proteins. There are six specific physicochemical properties than affect their solution behavior and, in turn, their long-term stability in aqueous vehicles. These are (i) maximal chemical instability, (ii) unusual or fluxional higher order structure, (iii) high degree of surface activity, (iv) marked propensity to self-associate, (v) significant solubility in nonaqueous solvents, and (vi) complex aggregation behavior, including proclivity towards gelation. Each of these factors will be discussed in the context of formulation development, as illustrated by the peptide literature. What emerges is the need to consider peptide formulation as a distinct field of activity, not just a subset of protein formulation, although there are some common features.
Dr. Manning has been involved in the development of biopharmaceutical products since 1988, when he joined the faculty at the University of Kansas. He then moved to the University of Colorado, where he helped found the Center for Pharmaceutical Biotechnology, what is widely considered to be the leading educational program in the country for training formulation scientists to handle biotechnology-based products. Dr. Manning has consulted for over 40 companies on a wide variety of projects. In addition, he has directed numerous formulation development projects for clients, first as CTO for HTD BioSystems and then as Chief Scientific Officer for Legacy BioDesign. Dr. Manning has published over 100 scientific articles, holds five US patents, and has edited three books on protein formulation. Dr. Manning received an A.B. degree in chemistry from Hope College and his M.S. and Ph.D. degrees from Northwestern University. He conducted post-doctoral work at Colorado State University.