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 |
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
- <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
- 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: