Cell and tissue

Reference Standards

USP-NF/PF

  • Tissue Human Amnion Chorion Membrane Dehydrated
  • Construct Human Fibroblasts in Bilayer Synthetic Scaffold
  • Construct Human Fibroblasts in Polyglactin Scaffold
  • Scaffold Porcine Small Intestinal Submucosa
  • Construct Human Keratinocytes and Fibroblasts In Bovine Collagen Scaffold
  • Scaffold Bovine Dermis
  • Scaffold Human Amniotic Membrane Allograft
  • Scaffold Porcine Bladder
  • Scaffold Silk Fibroin
  • Sipuleucel-T

USP-NF Monographs and General Chapters

  • <1129> Nucleic Acid-Based Techniques – Genotyping (STR, SNP, etc.)
  • <1285> Preparation of Biological Specimens for Histologic and Immunohistochemical Analysis
  • <1285.1> Hematoxylin and Eosin Staining of Sectioned Tissue for Microscopic Examination
  • <1127> Nucleic Acid-Based Techniques – Amplification 
  • <1027> Flow Cytometry 
  • <1102> Immunological Test Methods – General Considerations
  • <1046> Cell-Based Advanced Therapies and Tissue-Based Products
  • <1044> Cryopreservation of Cells
  • <1042> Cell Banking Practices for Recombinant Biologics
  • <1043> Ancillary Materials for Cell, Gene, and Tissue-Engineered Products
  • <1047> Gene Therapy Products
  • <1048> Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Products
  • <1049> Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products
  • <1071> rapid microbial testing
  • 〈1050〉 Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin 
  • 〈1049〉 Quality of Biotechnological Products: Stability Testing of Biotechnological / Biological Products