Executive Overview
SmaBio Labs provides comprehensive analytical testing and characterization services to support biologics throughout development. Our scientists work as an extension of our partners’ teams, helping evaluate critical quality attributes, assess product consistency, and generate reliable data for successful BLA submissions. By combining deep technical expertise with a collaborative approach, we help biotechnology and pharmaceutical companies overcome complex analytical challenges and move promising therapies closer to patients.
ADC Analytical Testing Capabilities
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End-to-End ADC Characterization
• Antibody, linker, payload, and conjugate-level testing
• DAR determination (UV, HIC, LC-MS)
• Conjugation site and distribution analysis
Protein & Polypeptide Analytical Testing Capabilities
Structural & Physicochemical Characterization
Structural & Physicochemical Characterization
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Molecular weight confirmation (intact, reduced, subunit LC-MS)
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Primary structure and sequence confirmation (peptide mapping)
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Higher-order structure assessment (CD, FTIR, DSC)
Purity, Heterogeneity & Impurity Profiling
Purity, Heterogeneity & Impurity Profiling
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Aggregates and fragments (SEC, SDS-PAGE, CE-SDS)
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Charge variants (IEX)
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Oxidation, deamidation, truncation, and related impurities
Polypeptide Testing
Polypeptide Testing
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Peptide identity and content (RP-HPLC, LC-MS)
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Related substances
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Residual solvents
Potency & Functional Assays
Potency & Functional Assays
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Binding and activity assays (cell-based or biochemical)
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Enzymatic activity and receptor interaction testing
