Cell and Tissue Standards

Standards Updates

Pharmacopeial Forum Updates

Documentary Standards Status
<1043> Ancillary Materials for Cell, Gene, and Tissue-engineered Products Published for comment in PF 43(4) on July 3, 2017, comments due September 30, 2017.
Scaffold Human Amnion Membrane Allograft Will be published for comment in PF 43(5) on September 1, 2017, comments due November 30, 2017.
<92> Growth Factors and Cytokines Used in Cell Therapy Manufacturing

Scaffold Human Placental Connective Tissue Matrix Allograft

In Development, slated for publication mid 2018

Official in USP 40–NF 35, May 1, 2017

Documentary Standards Associated Reference Standards
<127> Flow Cytometric Enumeration of CD34+ Cells (NEW)
For more information…
CD34+ Cell Enumeration System Suitability
<89.1> Collagenase I (Free Chapter Download)

<89.2> Collagenase II (Free Chapter Download)

Collagenase I

Collagenase II

Tissue Human Amnion Chorion Membrane Dehydrated (NEW)  

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Biologics Monographs 3 – Complex Biologics Expert Committee

USP's BIO3 Complex Biologics Expert Committee directs the organization's work on cell therapy and tissue product standards. Review the committee's workplan and learn more. Your feedback and questions are always welcome at celltissue@usp.org.