Biologics Standards

Ensuring quality throughout biologics development and manufacturing


Standards are a key to ensuring quality throughout your process and supporting regulatory filings.

Biologics standards:

  • Help ensure the quality and consistency of biological treatments reaching patients globally
  • Protect the integrity of the global medical supply chain for biologics
  • Provide a consistent benchmark for analytical testing throughout the product lifecycle
  • Support regulatory filings for new medicines
  • Set a common barometer of quality for evolving and ever more complex biologics

USP is the logical choice for consistency and reproducibility in Reference Standards for biologics. You can count on USP standards every step of the way.

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Engage and collaborate with USP


USP is looking for collaborators in all aspects of the standards development process. Below are just a few of the ways you and your company can get involved.

  • Collaborate with USP on development of new standards
  • Submit a proposal for new standards – method and material candidates
  • Comment on proposals in the Pharmacopeial Forum
  • Attend USP workshops
  • Observe expert committee or panel meetings
  • Participate in USP collaborative studies for Reference Standards evaluation

Feedback or questions?

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