USP’s popular peptide workshop is back for a third year. Here’s what you can expect.
The field of biologics is vast and growing, with tremendous potential to improve patients’ lives and public health.
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.
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.
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.
For a hundred years, federal law has required that all drugs adhere to public quality standards—part of ensuring safety and protecting the public’s health. Language that would exempt biologics, including biosimilars, from adhering to the same public quality standards as other prescription medicines was recently added to the FDA and NIH Workforce Authorities Modernization Act. Learn about the potential impact this biologics quality exemption may have on competition, product development, and the public's confidence in biologics and biosimilars.
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.