USP’s popular peptide workshop is back for a third year. Here’s what you can expect.
Assurances of safety and effectiveness play an important role in instilling confidence among healthcare providers in any new class of medicines. Those assurances include knowing that mandatory public standards for quality and naming have been adhered to in the manufacture of medicines. Find out what this means for top selling biologics in the U.S.
The American drug supply is among the safest in the world, with many protections for consumers and patients. However, a pending proposal in Congress would remove key protections for all biologic drugs—crucial and lifesaving medicines we take like insulin, human growth hormones, and blood thinners. Learn more.
Legislation being considered by Congress will remove the requirement that all biologic medicines – drugs such as insulin, vaccines, cancer treatments and other therapies made using living matter – comply with public quality standards of the U.S. Pharmacopeia (USP). This same legislation would also apply to biosimilars. As a result, public confidence in biologics and biosimilars as well as patient safety would be at risk. Learn more.
Learn about the evolving and challenging role of glycosylation analysis in biopharmaceutical science and how USP documentary and reference standards can support advances in this field.
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.
