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ADVANCED ANALYTICAL TESTING FOR BIOLOGICS DEVELOPMENT

Delivering the data, insights and analytical expertise needed to advance biologic therapies with confidence

Overview

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 

Core Analytics

End-to-End ADC Characterization 

  • Antibody, linker, payload, and conjugate-level testing 

  • DAR determination (UV, HIC, LC-MS) 

  • Conjugation site and distribution analysis 

Advanced Separation & Detection 

  • HIC, SEC, IEX, RP-HPLC 

  • Intact mass and subunit LC-MS 

  • Peptide mapping and payload-related impurity profiling 

Potency, Release & Stability Testing 

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  • In vitro drug release (free payload, linker cleavage) 

  • Stability studies under ICH conditions, including low temperatures (-20°C to -80°C) 

Bioanalytical & Safety-Relevant Assays 

  • Free vs. conjugated drug quantification 

  • Aggregation, fragmentation, and charge variant analysis 

  • Residual solvents, elemental impurities, and extractables support 

Protein & Polypeptide Analytical Testing Capabilities 

Structural & Physicochemical Characterization 

  • Molecular weight confirmation (intact, reduced, subunit LC-MS) 

  • Primary structure and sequence confirmation (peptide mapping) 

  • Higher-order structure assessment (CD, FTIR, DSC) 

Purity, Heterogeneity & Impurity Profiling 

  • Aggregates and fragments (SEC, SDS-PAGE, CE-SDS) 

  • Charge variants (IEX) 

  • Oxidation, deamidation, truncation, and related impurities 

Polypeptide Testing 

  • Peptide identity and content (RP-HPLC, LC-MS) 

  • Related substances 

  • Residual solvents 

Potency & Functional Assays 

  • Binding and activity assays (cell-based or biochemical) 

  • Enzymatic activity and receptor interaction testing 

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