Cell and tissue

USP Monographs

• Chymotrypsin
  • Reference Standard: USP Chymotrypsin RS
  • Reference Standard: USP Trypsin Bovine RS
• Insulin Human
  • Reference Standard: USP Insulin Human RS
• Trypsin
  • Reference Standard: USP Trypsin Bovine RS 
  • Reference Standard: USP Trypsin Recombinant Porcine RS
• Construct Human Fibroblasts in Polyglactin Scaffold
  • Reference Standard: USP Authentic Visual References RS
  • Reference Standard: USP Construct Human Fibroblasts in Polyglactin Scaffold Reference Photomicrographs
• Tissue Human Amnion Chorion Membrane Dehydrated
• Construct Human Fibroblasts in Bilayer Synthetic Scaffold
  • Reference Standard: USP Authentic Visual References RS
• Construct Human Fibroblasts in Polyglactin Scaffold
  • Reference Standard: USP Authentic Visual References RS
  • Reference Standard: USP Construct Human Fibroblasts in Polyglactin Scaffold Reference Photomicrographs
• Scaffold Porcine Small Intestinal Submucosa
  • Reference Standard: USP Authentic Visual References RS 
  • Reference Standard: USP Cultured Rat Pheochromocytoma Reference Photomicrographs
• Construct Human Keratinocytes and Fibroblasts in Bovine Collagen Scaffold
  • Reference Standard: USP Authentic Visual References RS
• Scaffold Bovine Dermis
  • Reference Standard: USP Authentic Visual References RS
• Scaffold Human Dermis
  • Reference Standard: USP Authentic Visual References RS
• Scaffold Human Amniotic Membrane Allograft
• Scaffold Porcine Bladder
• Sipuleucel-T
• Scaffold Silk Fibroin

USP-NF Chapters

• 〈61〉 Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests
• 〈62〉 Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
• 〈63〉 Mycoplasma Tests
• 〈71〉 Sterility Tests
• 〈85〉 Bacterial Endotoxins Test
  • Reference Standard: USP Endotoxin RS
• 〈87〉 Biological Reactivity Tests, In Vitro
  • Reference Standard: USP High-Density Polyethylene RS
• 〈88〉 Biological Reactivity Tests, In Vivo
  • Reference Standard: USP High-Density Polyethylene RS
• 〈89〉 Enzymes Used as Ancillary Materials in Pharmaceutical Manufacturing
  • Reference Standard: USP Trypsin Recombinant Porcine RS
• 〈89.1〉 Collagenase I
  • Reference Standard: USP Collagenase I RS
• 〈89.2〉 Collagenase II
  • Reference Standard: USP Collagenase II RS
• 〈90〉 Fetal Bovine Serum—Quality Attributes and Functionality Tests
  • Reference Standard: USP Fetal Bovine Serum RS
• 〈92〉 Growth Factors and Cytokines Used in Cell Therapy Manufacturing
  • Reference Standard: USP rHuman Interleukin 4 RS
• 〈127〉 Flow Cytometric Enumeration of CD34+ Cells
  • Reference Standard: USP CD34+ Cell Enumeration System Suitability
• 〈507〉 Protein Determination Procedures
  • Reference Standard: USP BSA for Protein Quantitation RS
• 〈785〉Osmolality and Osmolarity
• 〈788〉 Particulate Matter in Injections
  • Reference Standard: USP Particle Count RS
• 〈789〉 Particulate Matter in Ophthalmic Solutions
• 〈790〉 Visible Particulates in Injections
• 〈791〉 pH
• 〈1024〉 Bovine Serum
• 〈1027〉 Flow Cytometry
• 〈1042〉 Cell Banking Practices for Recombinant Biologics
• 〈1043〉 Ancillary Materials for Cell, Gene, and Tissue-Engineered Products
• 〈1044〉 Cryopreservation of Cells
• 〈1046〉 Cell-Based Advanced Therapies and Tissue-Based Products
• 〈1049〉 Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products
• 〈1050〉 Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
• 〈1071〉 Rapid Sterility Testing of Short Life Products A Risk Based Approach
• 〈1085〉 Guidelines on the Endotoxins Test
• 〈1103〉 Immunological Test Methods—Enzyme-Linked Immunosorbent Assay (Elisa)
• 〈1104〉 Immunological Test Methods—Immunoblot Analysis
• 〈1125〉 Nucleic Acid-Based Techniques—General
• 〈1126〉 Nucleic Acid-Based Techniques—Extraction, Detection, and Sequencing
• 〈1127〉 Nucleic Acid-Based Techniques—Amplification
• 〈1128〉 Nucleic Acid-Based Techniques—Microarray
• 〈1130〉 Nucleic Acid-Based Techniques—Approaches for Detecting Trace Nucleic Acids (Residual DNA Testing)
• 〈1132〉 Residual Host Cell Protein Measurement in Biopharmaceuticals
• 〈1285〉 Preparation of Biological Specimens for Histologic and Immunohistochemical Analysis
• 〈1285.1〉 Hematoxylin and Eosin Staining of Sectioned Tissue for Microscopic Examination
• 〈1430.3〉 Analytical Methodologies Based on Scattering Phenomena—Dynamic Light Scattering
• 〈1776〉 Image Analysis of Pharmaceutical Systems
• 〈1787〉 Measurement of Subvisible Particulate Matter in Therapeutic Protein Injections
• 〈1788.3〉 Flow Imaging Method for the Determination of Subvisible Particulate Matter
• 〈1790〉 Visual Inspection of Injections