Advanced Analytical Testing for Biologics Development
Delivering the data, insights and analytical expertise needed to advance biologic therapies with confidence
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.
Supports
- BLA
- ICH stability conditions
- ADC
- Proteins
- Polypeptides
Capabilities
A ADC Analytical Testing Capabilities
End-to-End ADC Characterization
DAR · UV · HIC · LC-MS
- 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
- HIC, SEC, IEX, RP-HPLC
- Intact mass and subunit LC-MS
- Peptide mapping and payload-related impurity profiling
Potency, Release & Stability Testing
ICH conditions · to −80 °C
- In vitro drug release (free payload, linker cleavage)
- Stability Studies under ICH conditions, including low temperatures (-20C to -80C)
Bioanalytical & Safety-Relevant Assays
- Free vs. conjugated drug quantification
- Aggregation, fragmentation, and charge variant analysis
- Residual solvents, elemental impurities, and extractables support
B Protein & Polypeptide Analytical Testing Capabilities
Structural & Physicochemical Characterization
LC-MS · CD · FTIR · DSC
- 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
SEC · SDS-PAGE · CE-SDS · IEX
- Aggregates and fragments (SEC, SDS-PAGE, CE-SDS)
- Charge variants (IEX)
- Oxidation, deamidation, truncation, and related impurities
Polypeptide Testing
RP-HPLC · LC-MS
- 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
Quality · Compliance
Reliable data for successful BLA submissions.
- FDA-registered lab*
- Critical quality attributes
- Product consistency
- ICH conditions to −80 °C
- U.S.-based operations
- Successful client audits
*Analytical Lab