Proteins

Standards Updates

Stimuli to the Revision Process, in PF 43(6), comments due January 31, 2018.

Higher Order Structure of Proteins in Biopharmaceutical Development

Official in USP 41–NF 36, published Nov 1, 2017 | Official Date: May 1, 2018.

Documentary Standards Associated Reference Standards
Epoetin (NEW) Erythropoietin RS (Released)

Reference Standards

Released Reference Standards NEW Reference Standards in Development

Pancreatin Lipase #1494079
Corticotropin #1149004
Protamine Sulfate #1578612

CHO Genomic DNA

E. coli Genomic DNA

Filgrastim for Bioassay 

Interferon Beta 1A

Interferon Beta 1A for Bioidentity

Recent publications in Pharmacopieal Forum

Open for comment in Pharmacopieal Forum 44(1)

Published January 2, 2018, comments due March 31, 2018.

Documentary Standards Associated Reference Standards
Insulin Insulin (Beef)
Insulin Pork

Open for comment in Pharmacopieal Forum 44(2)

Published March 1, 2018, comments due May 31, 2018.

Documentary Standards Associated Reference Standards
<1055> Biotechnology-Derived Articles – Peptide Mapping  

Open for comment in Pharmacopieal Forum 43(6)

Published Nov 1, 2017, comments due January 31, 2018.

Documentary Standards Associated Reference Standards
Trypsin (was Crystallized Trypsin) Trypsin Bovine
Trypsin Recombinant Porcine

Proposed New/Revised Documentary Standards

Documentary Standards Status

Interferon beta-1a

Interferon beta-1a Injection
Proposed new monographs scheduled to appear for public comment in spring 2018. For more information, contact Dr. Michael Huang at bmh@usp.org.
<xxxx> Biologics Stability

New General Chapter in development.

Free Official General Chapter Downloads

New Reference Standards Releases

Sign up to receive notices when new reference standards become available.

Sign Up

Collaborative Testing Opportunities

We are seeking collaborative test sites for the following proteins:

  • Interferon Beta 1a
  • Interferon Beta 1a for Bioidentity

Contact proteins@usp.org.

Protein Standards–Collaborate with USP

Building on the experience in setting standards for therapeutic proteins, USP is exploring opportunities to develop standards that are applicable across protein products. Areas for consideration are bioassay standards, chromatographic system suitability standards, and standards for critical reagents, in addition to standards for raw materials. USP welcomes recommendations from stakeholders regarding standards which would be useful in the development and release of therapeutic proteins. Comments and queries should be addressed to proteins@usp.org.

Monograph Modernization

As the role of biologic drugs continues to expand in the therapeutic arena, USP is committed to collaborating with scientific leaders in the biopharmaceutical community to update existing and develop new quality standards that support activities in the discovery, development, manufacturing, and distribution of biologics. Learn more about the development and revision process and how you can get involved.
USP is actively seeking sponsors for the modernization of the following protein monographs:

  • Papain
  • Papain Tablets for Topical Solution
  • Lactase
  • Lactase Tablets
  • Sargramostim
  • Sargramostim for Injection
  • Aprotinin
  • Hyaluronidase for Injection

To learn more about modernization, please contact us, at biotech@usp.org

Our work with proteins is guided by scientific experts from a variety of disciplines and industries. Find out what these Expert Committees are up to by reviewing their workplans: