Cell and Tissue Standards

Standards Updates

Pharmacopeial Forum Updates

Documentary Standards Status
<1046> Cell and Tissue-based Products in 44(6) Comment ending period November 30th 2018
<92> Growth Factors and Cytokines Used in Cell Therapy Manufacturing

Scaffold Human Placental Connective Tissue Matrix Allograft

In development, slated for publication in PF November 2018.
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


<1044> Cryopreservation of Cells (Free Chapter Download)


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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 biotech@usp.org.