Ancillary Materials Standards
Official in USP 40–NF 35 | Official Date: May 1, 2017
| Documentary Standards | Associated Reference Standards |
| <89.1> Collagenase I (Free Chapter Download) | Collagenase I |
| <89.2> Collagenase II (Free Chapter Download) | Collagenase II |
Proposed General Chapter Revision
| Documentary Standards | Status |
| <92> Growth Factors and Cytokines used in Cell Therapy Manufacturing |
Targeting publication in PF 44(6), Nov. 1, 2018. Comment period ends January 31, 2019. For more information, contact Dr. Rebecca Potts at rcp@usp.org. Related reference standard: rHuman Interleukin 4 |
Related USP-NF General Chapters
| Documentary Standards | Associated Reference Standards |
| <89> Enzymes used as Ancillary Materials in Pharmaceutical Manufacturing | Trypsin Recombinant Porcine |
| <90> Fetal Bovine Serum Quality Attributes and Functionality Tests | Fetal Bovine Serum |
| <130> Protein A Quality Attributes | Protein A; rProtein A; rProtein A, C-Cys |
Raw Materials Standards–Collaborate with USP
Building on the experience gained from developing standards for ancillary materials used in cell and tissue engineered products manufacturing, USP is committed to identifying opportunities to set standards for raw materials used in biomanufacturing. While USP evaluates the type of raw materials for which documentary and reference standards may be developed, we welcome stakeholder feedback. Queries and comments should be addressed to rawancillary@usp.org.
Expert Committees
Our raw and ancillary materials work 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: