USP’s popular peptide workshop is back for a third year. Here’s what you can expect.
USP was founded nearly 200 years ago by eleven doctors who wanted to ensure that the nation had access to quality medicines. They put together the first pharmacopeia, a book of recipes for making tinctures, extracts, and other medicines.
In conversations about the role of quality standards in public health, you might come across the words “compendia” and “compendial.” At USP, terms like “compendial approaches,” “compendial standards,” and “compendial tools” are part of our everyda
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.
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.
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.