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Chart 5.

Biotechnology-Derived Drug Products


Identification
<11> USP Reference Standards
<121> Insulin Assays
<121.1> Physicochemical Analytical Procedures
for Insulins
<123> Glucagon Bioidentity Tests
<191> Identification TestsGeneral
<197> Spectrophotometric Identification Tests
<621> Chromatography
<726> Electrophoresis
<736> Mass Spectrometry
<761> Nuclear Magnetic Resonance Spectroscopy
<851> Spectrophotometry and Light-Scattering
<1030> Biological Assay ChaptersOverview and
Glossary
<1032> Design and Development of Biological
Assays
<1033> Biological Assay Validation
<1034> Analysis of Biological Assays
<1045> Biotechnology-Derived Articles
<1052> Biotechnology-Derived Articles
Amino Acid Analysis
<1053> Capillary Electrophoresis
<1054> Biotechnology-Derived Articles
Isoelectric Focusing
<1055> Biotechnology-Derived Articles
Peptide Mapping
<1056> Biotechnology-Derived Articles
Polyacrylamide Gel Electrophoresis
<1057> Biotechnology-Derived Articles
Total Protein Assay
<1102> Immunological Test MethodsGeneral
Considerations
<1103> Immunological Test MethodsEnzymeLinked Immunosorbent Assay (ELISA)
<1104> Immunological Test MethodsImmunoblot
Analysis
<1761> Applications of Nuclear Magnetic Resonance
Spectroscopy

Characterization
<111> Design and Analysis of Biological Assays
<121.1> Physicochemical Analytical Procedures
for Insulins
<621> Chromatography
<726> Electrophoresis
<736> Mass Spectrometry
<761> Nuclear Magnetic Resonance Spectroscopy
<851> Spectrophotometry and Light-Scattering
<1030> Biological Assay ChaptersOverview and Glossary
<1032> Design and Development of Biological Assays
<1033> Biological Assay Validation
<1034> Analysis of Biological Assays
<1044> Cryopreservation of Cells
<1045> Biotechnology-Derived Articles
<1052> Biotechnology-Derived Articles
Amino Acid Analysis
<1053> Capillary Electrophoresis
<1054> Biotechnology-Derived Articles
Isoelectric Focusing
<1055> Biotechnology-Derived Articles
Peptide Mapping
<1056> Biotechnology-Derived Articles
Polyacrylamide Gel Electrophoresis
<1057> Biotechnology-Derived Articles
Total Protein Assay
<1084> Glycoprotein and Glycan Analysis
General Considerations
<1102> Immunological Test MethodsGeneral
Considerations
<1103> Immunological Test MethodsEnzymeLinked Immunosorbent Assay (ELISA)
<1104> Immunological Test MethodsImmunoblot Analysis
<1105> Immunological Test MethodsSurface
Plasmon Resonance
<1181> Scanning Electron Microscopy
<1761> Applications of Nuclear Magnetic Resonance
Spectroscopy

Equipment
<21> Thermometers
<31> Volumetric Apparatus
<41> Balances
<1251> Weighing on an Analytical Balance

Miscellaneous Tests
<1> Injections
<660> ContainersGlass
<661> ContainersPlastics
<671> ContainersPerformance Testing
<788> Particulate Matter in Injections

Description
<631> Color and Achromicity
<695> Crystallinity
<791> pH
<1041> Biologics
<1121> Nomenclature

Safety

Physicochemical

<11> USP Reference Standards


<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
<87> Biological Reactivity Tests, In Vitro
<88> Biological Reactivity Tests, In Vivo
<151> Pyrogen Test
<341> Antimicrobial AgentsContent
<1050> Viral Safety Evaluation of Biotechnology
Products Derived from Cell Lines of
Human or Animal Origin
<1106> Immunogenicity AssaysDesign and
Validation of Immunoassays to Detect
Anti-Drug Antibodies
<1111> Microbiological Examination of
Nonsterile Products: Acceptance
Criteria for Pharmaceutical Preparations
and Substances for Pharmaceutical Use
<1113> Microbial Characterization, Identification,
and Strain Typing
<1130> Nucleic Acid-Based Techniques
Approaches for Detecting Trace Nucleic
Acids (Residual DNA Testing)
<1211> Sterilization and Sterility Assurance of
Compendial Articles
<1229> Sterilization of Compendial Articles
<1229.4> Sterilizing Filtration of Liquids

Assay
<11> USP Reference Standards
<111> Design and Analysis of Biological Assays
<121> Insulin Assays
<208> Anti-factor Xa and Anti-factor IIa Assays for
Unfractionated and Low Molecular Weight
Heparins
<541> Titrimetry
<621> Chromatography
<726> Electrophoresis
<736> Mass Spectrometry
<761> Nuclear Magnetic Resonance Spectroscopy
<781> Optical Rotation
<851> Spectrophotometry and Light-Scattering
<1030> Biological Assay ChaptersOverview and
Glossary
<1032> Design and Development of Biological
Assays
<1033> Biological Assay Validation
<1034> Analysis of Biological Assays
<1044> Cryopreservation of Cells
<1045> Biotechnology-Derived Articles
<1052> Biotechnology-Derived Articles
Amino Acid Analysis
<1053> Capillary Electrophoresis
<1054> Biotechnology-Derived Articles
Isoelectric Focusing
<1055> Biotechnology-Derived Articles
Peptide Mapping
<1056> Biotechnology-Derived Articles
Polyacrylamide Gel Electrophoresis
<1057> Biotechnology-Derived Articles
Total Protein Assay
<1102> Immunological Test MethodsGeneral
Considerations
<1103> Immunological Test MethodsEnzymeLinked Immunosorbent Assay (ELISA)
<1105> Immunological Test MethodsSurface
Plasmon Resonance
<1125> Nucleic Acid-Based TechniquesGeneral
<1126> Nucleic Acid-Based Techniques
Extraction, Detection, and Sequencing
<1127> Nucleic Acid-Based Techniques
Amplification
<1129> Nucleic Acid-Based Techniques
Genotyping
<1761> Applications of Nuclear Magnetic
Resonance Spectroscopy

<11> USP Reference Standards


<121.1> Physicochemical Analytical Procedures
for Insulins
<621> Chromatography
<726> Electrophoresis
<736> Mass Spectrometry
<761> Nuclear Magnetic Resonance Spectroscopy
<785> Osmolality and Osmolarity
<786> Particle Size Distribution Estimation by
Analytical Sieving
<791> pH
<831> Refractive Index
<851> Spectrophotometry and Light-Scattering
<1045> Biotechnology-Derived Articles
<1052> Biotechnology-Derived Articles
Amino Acid Analysis
<1053> Capillary Electrophoresis
<1054> Biotechnology-Derived Articles
Isoelectric Focusing
<1055> Biotechnology-Derived Articles
Peptide Mapping
<1056> Biotechnology-Derived Articles
Polyacrylamide Gel Electrophoresis
<1057> Biotechnology-Derived Articles
Total Protein Assay
<1084> Glycoprotein and Glycan Analysis
General Considerations
<1065> Ion Chromatography
<1761> Applications of Nuclear Magnetic Resonance
Spectroscopy

Impurities
Process Related

Product Related

<11> USP Reference Standards


<61> Microbiological Examination of Nonsterile
Products: Microbial Enumeration Tests
<62> Microbiological Examination of Nonsterile
Products: Tests for Specified Microorganisms
<63> Mycoplasma Tests
<90> Fetal Bovine Serum Quality Attributes and
Functionality Tests
<111> Design and Analysis of Biological Assays
<121.1> Physicochemical Analytical Procedures
for Insulins
<130> Protein A Quality Attributes
<231> Heavy Metals
<232> Elemental ImpuritiesLimits
<233> Elemental ImpuritiesProcedures
<467> Residual Solvents
<503> Acetic Acid In Peptides
<541> Titrimetry
<621> Chromatography
<726> Electrophoresis
<730> Plasma Spectrochemistry
<731> Loss on Drying
<736> Mass Spectrometry
<761> Nuclear Magnetic Resonance Spectroscopy
<851> Spectrophotometry and Light-Scattering

<11> USP Reference Standards


<111> Design and Analysis of
Biological Assays
<121.1> Physicochemical
Analytical Procedures
for Insulins
<621> Chromatography
<726> Electrophoresis
<736> Mass Spectrometry
<761> Nuclear Magnetic
Resonance
<1102> Immunological Test
MethodsGeneral
Considerations
<1103> Immunological Test
MethodsEnzymeLinked Immunosorbent
Assay (ELISA)
<1104> Immunological Test
MethodsImmunoblot
Analysis
<1761> Applications of Nuclear
Magnetic Resonance
Spectroscopy

<921> Water Determination


<1024> Bovine Serum
<1045> Biotechnology-Derived Articles
<1052> Biotechnology-Derived ArticlesAmino Acid Analysis
<1053> Capillary Electrophoresis
<1054> Biotechnology-Derived ArticlesIsoelectric Focusing
<1055> Biotechnology-Derived ArticlesPeptide Mapping
<1056> Biotechnology-Derived ArticlesPolyacrylamide Gel Electrophoresis
<1057> Biotechnology-Derived ArticlesTotal Protein Assay
<1084> Glycoprotein and Glycan Analysis General Considerations
<1102> Immunological Test MethodsGeneral Considerations
<1103> Immunological Test MethodsEnzyme-Linked Immunosorbent Assay
(ELISA)
<1104> Immunological Test MethodsImmunoblot Analysis
<1113> Microbial Characterization, Identification, and Strain Typing
<1125> Nucleic Acid-Based TechniquesGeneral
<1126> Nucleic Acid-Based TechniquesExtraction,
Detection, and Sequencing
<1127> Nucleic Acid-Based TechniquesAmplification
<1128> Nucleic Acid-Based TechniquesMicroarray
<1129> Nucleic Acid-Based TechniquesGenotyping
<1130> Nucleic Acid-Based TechniquesApproaches for Detecting Trace
Nucleic Acids (Residual DNA Testing)
<1761> Applications of Nuclear Magnetic Resonance Spectroscopy