Additional Supporting Resources
In-Process Testing
Concentration
Determination of the number of molecules per unit volume, expressed in milligrams per milliliter.Process Related Impurities
Tests for substances like host cell proteins that are produced during the manufacturing processResidual DNA
Reference Standards
Documentary Standards (USP-NF)
Other Resources
Host Cell Proteins
Documentary Standards (USP-NF)
<1102> Immunological Test Methods—General Considerations
<1103> Immunological Test Methods—Enzyme-Linked Immunosorbent Assay (ELISA)
<1132> Residual Host Cell Protein Measurement in Biopharmaceuticals
<1132.1> Residual Host Cell Protein Measurement in Biopharmaceuticals by Mass Spectrometry
Analytical Reference Materials
1582716: PLBL2 (Phospholipase B-like 2) Host Cell Protein
Stable Isotope Labeled (SIL) Peptides
1130730: CHO HCP Clusterin Heavy Peptide 1 NEW!
1130741: CHO HCP Clusterin Heavy Peptide 2 NEW!
1130752: CHO HCP Clusterin Heavy Peptide 3 NEW!
1130763: CHO HCP Lipoprotein Lipase Peptide 1 NEW!
1130774: CHO HCP Lipoprotein Lipase Peptide 2 NEW!
1130785: CHO HCP Lipoprotein Lipase Peptide 3 NEW!
USP Educational Content
Other Resources
Presentation: USP Standards Host Cell Protein Analysis by MS
Residual Proteins
(e.g. Protein A)
Charge Variants
Tests for acidic and basic variants which may be caused by deamidation or oxidationIon Exchange Chromatography
(IEX)
Documentary Standards (USP-NF)
USP Educational Content
Analysis of Charge Variants in Biologics
Other Resources
Poster: Standards for Cation Exchange Chromatography
Presentation: Reference Standards, Analysis of Charge Variants
Isoelectric focusing
(cIEF/iCIEF)
Reference Standards
1445539: USP mAb 001, monoclonal IgG1
1445547: USP mAb 002, monoclonal IgG1
1445595: USP mAb 003, monoclonal IgG1
USP Educational Content
Analysis of Charge Variants in Biologics
Documentary Standards (USP-NF)
<1053> Capillary Electrophoresis
<1054> Biotechnology-Derived Articles—Isoelectric Focusing
Other Resources
Presentation: Reference Standards, Analysis of Charge Variants
Peptide Mapping
Size Variants
Tests for protein aggregates and fragments that may form during manufacturing or storageIntact Mass
Reference Standards
1076192: BSA for Protein Quantitation
1445539: USP mAb 001, monoclonal IgG1
1445547: USP mAb 002, monoclonal IgG1
1445595: USP mAb 003, monoclonal IgG1
Documentary Standards (USP-NF)
<1736> Applications of Mass Spectrometry
Other Resources
SEC-MALS
(Multi-Angle Light Scattering)
Size Exclusion
(SEC-HPLC, SEC-UPLC)
CE-SDS
(Reduced and Non-Reduced)
SDS-PAGE
(Reduced and Non-Reduced)
Reference Standards
1445550: Monoclonal IgG System Suitability
1445539: USP mAb 001, monoclonal IgG1
1445547: USP mAb 002, monoclonal IgG1
1445595: USP mAb 003, monoclonal IgG1
Documentary Standards (USP-NF)
<129> Analytical procedures for recombinant therapeutic monoclonal antibodies
<1056> Biotechnology-Derived Articles—Polyacrylamide Gel Electrophoresis
Glycosylation
Tests for covalently attached sugars that can modulate biological activityN-Linked Glycan Profiling
Reference Standards
1478210: Oligosaccharide System Suitability Mixture A
1478221: Oligosaccharide System Suitability Mixture B
1478232 Oligosaccharide System Suitability Mixture C
1478243 Oligosaccharide System Suitability Mixture D
Documentary Standards (USP-NF)
<129> Analytical Procedures for Recombinant Therapeutic Monoclonal Antibodies
<212> Oligosaccharide Analysis
<1084> Glycoprotein and Glycan Analysis-General Considerations
Other Resources
Manuscript: USP mAb Ref Stds: Tools to Verify Glycan Structure
Manuscript: Comprehensive Stds for Monitoring Glycosylation
Monosaccharide Analysis
Reference Standards
1612619: N-Acetylneuraminic Acid
1294284: N-Glycolylneuraminic Acid
Documentary Standards (USP-NF)
Mass Spectrometry
Reference Standards
1445539: USP mAb 001, monoclonal IgG1
1445547: USP mAb 002, monoclonal IgG1
1445595: USP mAb 003, monoclonal IgG1
Documentary Standards (USP-NF)
<1736> Applications of Mass Spectrometry
Other Resources
Manuscript: Macro- and Micro-heterogeneity of Glycosylation
Safety
Tests for possible contamination with microorganisms.Endotoxin
Reference Standards
Documentary Standards (USP-NF)
Bioburden
Reference Materials
Documentary Standards (USP-NF)
<1229.3> Monitoring of Bioburden
<61> Microbiological Examination Of Nonsterile Products: Microbial Enumeration Tests
<62> Microbiological Examination Of Nonsterile Products: Tests For Specified Microorganisms
USP Educational Content
Essentials of Testing and Control of Microbial Quality of Nonsterile Drug Substances and Products
Sterility
Reference Materials
Documentary Standards (USP-NF)
<1071> Rapid Microbial Tests for Release of Sterile Short-Life Products: A Risk-Based Approach
USP Educational Content
Mycoplasma
Documentary Standards (USP-NF)