Comprehensive Analytical Services for the Pharmaceutical Industry
Supporting IND, NDA, 510 (k), BLA, ANDA, and Commercial Programs Across Small Molecules, Peptides, and Biologics
Executive Overview
SmaBio Labs delivers end-to-end, cGMP-compliant analytical services designed to support pharmaceutical development from early research through commercialization. Our expertise spans small molecules, peptides, biologics, and complex APIs, with a strong focus on regulatory readiness for IND, NDA and ANDA submissions. By combining advanced instrumentation, scientific depth, and regulatory insight, we enable sponsors to accelerate development timelines while maintaining the highest standards of data integrity and compliance.
ADC Analytical Testing Capabilities
End-to-End ADC Characterization
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Antibody, linker, payload, and conjugate-level testing
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DAR determination (UV, HIC, LC-MS)
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Conjugation site and distribution analysis
Advanced Separation & Detection
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HIC, SEC, IEX, RP-HPLC
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Intact mass and subunit LC-MS
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Peptide mapping and payload-related impurity profiling
Potency, Release & Stability Testing
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In vitro drug release (free payload, linker cleavage)
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Stability Studies under ICH conditions, including low temperatures (-20C to -80C)
Bioanalytical & Safety-Relevant Assays
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Free vs. conjugated drug quantification
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Aggregation, fragmentation, and charge variant analysis
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Residual solvents, elemental impurities, and extractables support
Protein & Polypeptide Analytical Testing Capabilities
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
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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
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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
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Binding and activity assays (cell-based or biochemical)
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Enzymatic activity and receptor interaction testing