Bioconjugate Analytical Development
- Services
- Bioconjugate Development Services
- Bioconjugate Analytical Development
LOTTE Biologics provides integrated analytical development and characterization services for bioconjugates, supporting product understanding, process development, quality, and regulatory readiness.
From method development and phase-appropriate qualification to comprehensive characterization, our analytical capabilities support critical quality attributes throughout development and commercialization.
Analytical Development & Optimization
Fit-for-purpose analytical methods designed to support bioconjugate development from early-stage programs through commercialization.
Analytical method Development & Optimization
Phase-appropriate Qualification & Validation
Product / Impurity Characterization
Process-Based Analytical Services
Monitoring critical quality attributes (CQAs) throughout the bioconjugate manufacturing process—from raw materials to final product
to drive process understanding, consistent quality, and regulatory readiness.
Raw Material Testing
IPC Testing: Conjugation
IPC Testing: Purification
Quality Assessment
Comprehensive Bioconjugate Characterization
In-depth analysis across antibodies, conjugates, linker-payloads, and functional attributes to enable deeper product understanding and informed development decisions.
Antibody Characterization
- Post-translational Modifications
- Disulfide bond mapping
- Fragments
- Glycosylation
- Cell based assay
- Binding activity
- HCP ID / Quantification
Antibody-Conjugate Characterization
- By Critical Quality Attributes
- Peak Characterization (for release items)
- Trace metals ID
- Stability studies (Forced degradation)
Fc Function
- Effector function (ADCC, CDC)
- FcRn Binding affinity
- Conjugation site engineering screening
Linker-Payload Characterization
- Drug-to-Antibody Ratio (DAR)
- Drug load distribution