Anita Szajek, Ph.D., principal scientific liaison to USP’s Expert Panel on Therapeutic Peptides, examines therapeutic peptides, the transition from recombinant to synthetic manufacturing routes, and regulatory and quality-related questions.
For the first time in more than 20 years, U.S. regulators are considering the reintroduction of bovine (cow-derived) heparin into the U.S., helping to address concerns about potential shortages and adulteration issues associated with this widely-used drug.
Today, peptides represent one of the fastest growing segments in the pharmaceutical market. Hence, being able to manufacture peptides that are consistent in makeup and quality is an important priority for manufacturers of this drug class. This article discusses how the global pharmaceutical landscape continues to transform and how quality standards will play a growing role in the manufacture of these drugs.