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.
Monographs
- Octoxynol 9 (NF)
- L-Alanyl-L-glutamine (DS)
- Glutamine (USP)
- Poloxamer (NF)
- Dextrose (USP)
- Dextrose excipient (NF)
- Magnesium Chloride (USP)
- Dimethyl Sulfoxide (USP)
Reference Standards
- Endotoxin
- Trypsin Recombinant Porcine
- Nonoxynol 9
- Octoxynol 9
- Glutamine
- L-Alanine
- L-Alanyl-L-alanine
- L-Alanyl-L-glutamine
- Poloxamer Liquid
- Poloxamer Solid
- Dextrose
- Fructose
- Maltose Monohydrate
- Maltotriose
- Dimethyl Sulfoxide
Analytical Reference Materials
- Quantitative HEK-293 Genomic DNA ARM
- Quantitative Sf9 Genomic DNA ARM
USP-NF Chapters
<61>, <62>, <63>, <71>, <85>, <89>, <507>, <509> with revision, <785>, <788>, <789>, <790>, <791>, <1040> (in PF), <1042>, <1043>, <1044>, <1047>, <1050>, <1103>, <1104>, <1126>, <1127>, <1130>, <1132>, <1430.3>, <1776>, <1787>, <1788.3>, <1790>
Reference Standards
- Chymotrypsin
- Endotoxin
- Insulin Human
- Trypsin Recombinant Porcine
- BSA for Protein Quantitation
- CD34+ Cell Enumeration System Suitability
- Collagenase I
- Collagenase II
- Fetal Bovine Serum
- rHuman Interleukin 4
- Cryopreserved Human Fibroblast-Derived Dermal Substitute Reference Photomicrographs (CD)
- Cultured Rat Pheochromocytoma Reference Photomicrographs (CD)
- Graftskin Reference Photomicrographs (CD)
- Human Fibroblast-Derived Skin Substitute Reference Photomicrographs (CD)
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
Reference Standards & Analytical Reference Materials
USP-NF Monographs and General Chapters
- <1047> Gene Therapy Products
- <1043> Ancillary Materials for Cell, Gene, and Tissue-Engineered Products
- <85> Bacterial Endotoxins Test
- <1085> Guidelines on Endotoxin Test
- <87> Biological Reactivity Tests – In Vitro
- <88> Biological Reactivity Tests – In Vivo
- <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
- <1127> Nucleic Acid-Based Techniques -- Amplification
- <1027> Flow Cytometry
- <1040> Quality Considerations of Plasmid DNA as a Starting Material for Cell and Gene Therapies, in PF49(6)
- <1129> Nucleic Acid-Based Techniques – Genotyping (including SNP, STR, etc.)
- <1040> Quality Considerations of Plasmid DNA as a Starting Material for Cell and Gene Therapies, in PF49(6)
- <1071> Rapid Microbial Testing
- <1050> Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
USP hosts Stakeholder Forum on Innovative Analytical Approaches to Cell & Gene Therapy
USP and ATCC deliver Webinar on Residual DNA Testing Solutions
Resources
Publications
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Education
- Viral Vector Manufacturing and Control Strategies
- Quality Considerations for Plasmid DNA as a Starting Material for Cell and Gene Therapies
- USP Standards and Best Practices for Gene Therapy
- What’s New in Biologics? Standards to Support Advanced Therapies
- Opportunities and Challenges in Raw Material and Starting Material Qualification for Cell and Gene Therapy Products
- Qualification of Raw Materials Used in the Manufacturing of Cellular Therapies
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