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.
One of the most transformative trends in pharma in recent years has been the explosive growth in biologic drug development. While these medicines have opened doors for treating many different cancers, autoimmune disorders, and chronic diseases such as diabetes, biologics have presented some new challenges related to packaging systems.
