Raw and Ancillary Materials

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 ArProtein ArProtein A, C-Cys

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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: