Our Expertise
Our team delivers clear, reliable insights at every stage of drug development through advanced instrumentation and rigorous analysis. We provide testing and data interpretation for drug substances and products, ensuring quality, safety, and efficacy. Core capabilities include method development and validation, quality control, characterization, stability, and bioanalytical services supporting small molecules, nucleic acids, and large molecules from preclinical through late-stage development.
Large Molecule Characterization
ADCs contain complex antibody components requiring detailed testing to confirm structural integrity, conjugation sites, and biological function. Using advanced CE, LC-MS, and HPLC methods, we assess protein identity, purity, structure, and stability. Additional evaluations including cytokine-release, bioburden, endotoxin, heavy metal, forced-degradation, and comparability studies ensure product integrity and performance throughout development.
Critical Quality Attributes
Methods Supported
Identification
• CE and cIEF profiling for antibody identity (SCIEX PA 800).
• Intact and reduced LC-MS for molecular confirmation (e.g., SCIEX TripleTOF; Triple Quad for targeted peptide analysis).
Primary Structure
• Peptide mapping and sequence confirmation (SCIEX TripleTOF)
• Disulfide bond mapping (SCIEX TripleTOF)
• Glycan profiling by LC-MS (SCIEX TripleTOF / Triple Quad)
Purity/Integrity/Impurity
• HIC, RP, SEC, and IEX-HPLC with UV or MS detection for heterogeneity and size variants
• CE-SDS (R/NR) for fragments and aggregates, and icIEF for charge variants (SCIEX PA 800)
• Free payload and linker catabolite analysis by LC-MS/MS (SCIEX Triple Quad)
Content
• Protein titer and content by UV-Vis/BCA (BioTek Cytation 5)
• Peptide-based LC-MS quant for total Ab/ADC (Triple Quad)
Safety
• Cytokine-release assessment by ELISA and multiplex ECL (Cytation 5, MSD QuickPlex)
• Bioburden Testing
• Endotoxin Analysis
• Heavy Metal Analysis
Other
• Forced-degradation studies (PA 800, LC-MS, HPLC)
• Simple Western for conjugate integrity and lot comparability (Bio-Techne Jess)
• Appearance
• pH
• Conductivity
• Osmolality
Small Molecule Characterization
The small-molecule payload provides the ADC’s therapeutic activity and must be precisely characterized for potency, purity, and stability. Using LC-MS and HPLC methods, we confirm chemical identity, structure, and content through mass, retention, and fragmentation analyses. Supporting studies include impurity profiling, forced-degradation testing, and safety assessments for bioburden, endotoxin, heavy metals, and key physicochemical properties such as pH, conductivity, and osmolality.
Critical Quality Attributes
Methods Supported
Identification
• Exact mass and targeted identity by LC-MS
• Retention match by HPLC-UV
• DAR and quantify antibody and drug concentration by UV-VIS (Cytation 5)
Primary Structure
• Fragmentation for structure confirmation and site assignment by LC-MS/MS
Purity/Integrity/Impurity
• Area-percent purity by HPLC-UV
• Impurity profiling with mass IDs by LC-MS
• Forced-degradation studies by HPLC/LC–MS
Content
• Assay by HPLC-UV
• Quantitative Content by LC-MS
Safety
• Bioburden
• Endotoxin Analysis
• Heavy Metal Analysis
Other
• Appearance
• pH
• Conductivity
• Osmolality