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.
U.S. Pharmacopeia (USP) brought together preeminent thought leaders from industry, global health organizations, regulatory agencies, standards setting organizations and other stakeholders at its virtual Global Biologics Summit on June 11, 2020.
USP’s popular peptide workshop is back for a third year. Here’s what you can expect.
Over the past three decades, generic medicines have significantly increased patient access to quality treatment, while lowering healthcare costs in the United States. Learn how a new class of prescription drugs knows as biosimilars, offers the same hope of increased access and reduced costs.
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.
Learn about and view the new suite of physical and written standards that USP is developing to help biologics manufacturers develop and analyze therapeutic proteins. New general chapters address analytical procedures for monoclonal antibodies, oligosaccharides, and protein determination.
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.