Proteins

Standards Updates

Higher Order Structure of Proteins in Biopharmaceutical Development

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

Reference Standards

Proposed New/Revised Documentary Standards

Free Official General Chapter Downloads

• <124> Erythropoietin Bioassays
• <129> Analytical Procedures for Recombinant Therapeutic Monoclonal Antibodies
• <210> Monosaccharide Analysis
• <212> Oligosaccharide Analysis
• <1132> Residual Host Cell Protein Measurement in Biopharmaceuticals
• <507> Protein Determination Procedures
• <509> Residual DNA Testing

New Reference Standards Releases

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Collaborative Testing Opportunities

We are seeking collaborative test sites for the following proteins:

• Interferon Beta 1a for Bioidentity

Contact biotech@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 biotech@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:

• Biologics Monographs 1 – Peptides Expert Committee (includes Insulins)
• Biologics Monographs 2 – Proteins Expert Committee
• Biologics Monographs 3 – Complex Biologics
• General Chapters—Biological Analysis Expert Committee