USP Biologics Reference Standards for Biologics & peptides

USP: the logical choice for consistency and reproducibility in reference standards for biologics and peptides

Biologics at USP: empowering a healthier tomorrow

USP’s biologics program is the logical choice for:
  • Quality standards
  • Education
  • Resources
  • Collaborative opportunities

As an independent, non-profit, global standards setting organization, USP is your go-to collaborator for Reference Standards in biologics. Our public standards help ensure that quality medicines are available around the world.

USP engages with experts, regulatory agencies, and companies to deliver consistent, reproducible biologics standards based on rigorous science. Quality standards support manufacturers in performing analytical testing throughout the lifecycle of a biologic, delivering confidence to manufacturers, regulatory agencies, practitioners, and patients.

Learn how USP can help with standards, resources, education and opportunities for collaboration.

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Biologics at USP Blog

Welcome
USP’s biologics blog delivers trends and insights impacting the development, manufacture and regulatory approval of biologics. The blog covers a broad range of topics of interest to anyone working in the field of biopharmaceuticals. See the latest blog post below.

 

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Products: USP Biologics Reference Standards

USP is a global leader in the development of well characterized quality Reference Standards for biologics.  Below is a featured list of USP Reference Standards:

New Reference Standards

Performance Standards

  • USP IgG System Suitability
  • USP Oligosaccharide System Suitability Mixtures (A, B, C, D)
  • CD 34+ Cell Enumeration System Suitability
  • BSA for Protein Quantitation

More Quality Standards

  • Filgrastim
  • Erythropoietin
  • Calcitonin Salmon
  • Pegfilgrastim for bioassay
More information

Why are standards for biologics so important?

  • To help ensure the quality and consistency of biological treatments reaching patients globally
  • To protect the integrity of the global medical supply chain for biologics
  • To provide a consistent benchmark for analytical testing throughout the product lifecycle
  • To support regulatory filings for new medicines
  • To set a common barometer of quality for evolving and ever more complex biologics
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Subscribe to USP's Biologics Newsletter

USP’s biologics newsletter includes the latest information on the development, approval, and release of new standards for biologics.

Stay up-to-date on the latest USP news and announcements, and quickly access new events, collaborative opportunities, guidelines, webinars, and other valuable resources.

 

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