Cell, Gene, Tissue Standards

Cell, gene, and tissue therapies are revolutionizing modern healthcare, holding the promise to treat and even cure a spectrum of previously intractable conditions. USP is leading the charge to establish cutting edge standards in the cell and gene therapy arena, ensuring these novel therapies meet the highest quality, safety, and efficacy benchmarks. Working with industry frontrunners, medical experts, and regulators, USP is streamlining the transition of cell and gene therapies from ground-breaking research to mainstream clinical practice, making advanced treatments both effective and widely available. As the realm of cell and gene therapies expands, USP continues to lay the groundwork necessary for their quality product development, validation, and integration into global healthcare systems.


stakeholder forum

USP hosts Stakeholder Forum on Innovative Analytical Approaches to Cell & Gene Therapy


USP and ATCC deliver Webinar on Residual DNA Testing Solutions



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Reference Standards & Analytical Reference Materials

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USP-NF Monographs and General Chapters

  • Construct Human Fibroblasts in Bilayer Synthetic Scaffold
  • Scaffold Porcine Small Intestinal Submucosa
  • Construct Human Keratinocytes and Fibroblasts In Bovine Collagen Scaffold
  • Scaffold Human Dermis
  • Construct Human Fibroblasts iIn Polyglactin Scaffold
  • Scaffold Bovine Dermis
  • Scaffold Human Amniotic Membrane Allograft
  • Scaffold Porcine Bladder
  • Scaffold Silk Fibroin
  • Sipuleucel-T
  • <85> Bacterial Endotoxins Test
  • <1085> Guidelines on Endotoxin Test
  • <87> Biological Reactivity Tests – In Vitro
  • <88> Biological Reactivity Tests – In Vivo
  • <89> Enzymes Used as Ancillary Materials in Pharmaceutical Manufacturing
  • <89.1> Collagenase I
  • <89.1> Collagenase II
  • <90> Fetal Bovine Serum Quality Attributes and Functionality Tests
  • <92> Growth Factors and Cytokines Used in Cell Therapy Manufacturing
  • <507> Protein Determination Procedures
  • <1024> Bovine Serum
  • <1043> Ancillary Materials for Cell, Gene and Tissue Engineered Products
  • <1047> Gene Therapy Products
  • <1044> Cryopreservation of Cells
  • <1129> Nucleic Acid-Based Techniques -- Genotyping
  • <1125> Nucleic Acid-Based Techniques -- General
  • <1126> Nucleic Acid-Based Techniques -- Extraction, Detection and Sequencing
  • <1130> Nucleic Acid-Based Techniques -- Approaches for Detecting Trace Nucleic Acids (Residual DNA Testing)
  • <1128> Nucleic Acid-Based Techniques -- Microarray
  • <1285> Preparation of Biological Specimens for Histologic and Immunohistochemical Analysis
  • <1285.1> Hematoxylin and Eosin Staining of Sectioned Tissue for Microscopic Examination
  • <1046> Cell-Based Advanced Therapies and Tissue-Based Products
  • <1127> Nucleic Acid-Based Techniques -- Amplification
  • <1027> Flow Cytometry
  • <127> Flow Cytometric Enumeration Of CD34+ Cells
  • <1040> Quality Considerations of Plasmid DNA as a Starting Material for Cell and Gene Therapies, in PF49(6)

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