We deliver laboratory-focused support across Pharmaceutical Development & Manufacturing, advancing within Drug Substance Development to specialized Antibody-Drug Conjugate (ADC) Development. Our programs prepare monoclonal antibodies for conjugation, establish orthogonal analytics for identity, purity, and stability, and build platformable bench-scale processes with documentation that enables smooth progression to later manufacturing stages while remaining squarely in research and development.
Overview of Monoclonal Antibody Conjugate Development
Monoclonal antibody conjugates combine a selective IgG scaffold with a functional moiety to create a single, well-characterized macromolecule. Development hinges on the conjugation readiness of the antibody, definition of a site strategy compatible with the nominated chemistry, control of drug-to-antibody ratio (DAR) and heterogeneity, and comprehensive analytics. Intact and subunit LC–MS, HIC for DAR distribution, SEC for size variants, and peptide mapping for site localization support specification setting and stability assessment. We prioritize small-volume experiments that mirror scale-aware operations and generate traceable, decision-grade data packages suitable for advancement, all within R&D drug-substance scope.
Our Services
The services below can be combined into a cohesive program or accessed as stand-alone modules.
Conjugation-Readiness & Developability Assessment Service
We profile supplied monoclonal antibodies for attributes that influence conjugation performance: free thiol content, glycan pattern, lysine distribution, isoelectric point, aggregation propensity, and buffer compatibility. Using targeted stress studies and biophysical panels, we define workable pH ranges, redox windows, and excipient sets. The output is a concise "conjugation-fit" brief with recommended handling conditions, allowable hold times, and readiness gates.
Site Strategy & Control of Heterogeneity Service
We evaluate lysine-based modification, controlled interchain disulfide reduction/rebridging, engineered-cysteine attachment, glycan-directed approaches, and enzyme-mediated methods as appropriate for monoclonal antibody frameworks. Through fine control of partial reduction, stoichiometry, and capping, we tune DAR targets and suppress off-target modification. Peptide-level LC–MS/MS mapping quantifies site occupancy, creating traceability for subsequent comparability work.
Conjugation Feasibility & Bridging Service
Working with a nominated conjugation chemistry, we adapt reaction parameters—order of addition, co-solvent use, temperature control, and quench/cap options—to the specific antibody. We run micro- to bench-scale studies to demonstrate feasibility, define hold points, and generate material for analytics. Outputs include a conditions matrix, acceptance ranges, and a succinct feasibility report suitable for internal review.
Conjugation Process Development Service
We construct a scalable bench protocol defining stoichiometry, mixing and feed strategies, temperature and time controls, and inline/at-line checks. Purification trains—UF/DF for buffer exchange, SEC for polishing, and HIC/IEX where appropriate—are configured to efficiently remove aggregates and unbound small molecules. Critical process parameters (CPPs) and in-process controls (IPCs) are established, accompanied by visual flow charts and draft batch records suitable for technology hand-off when required.
Analytical Method Development & Characterization Service
We build a method suite with orthogonal coverage: intact and subunit LC–MS for identity, HIC for DAR distribution, SEC-HPLC for size variants, CE-SDS/capillary methods for purity, peptide mapping for site localization, and targeted assays for residual reagents and solvents. Mini-validation (specificity, linearity, precision) supports reliable trend monitoring in R&D and enables clear acceptance criteria for process and stability studies.
Our Monoclonal Antibody Conjugate Portfolio
We concentrate on widely adopted, analytically tractable monoclonal antibody (mAb) formats that emphasize manufacturability, stability, and clear characterization.
- IgG Subclass Frameworks: Standard IgG1, IgG2, and IgG4 scaffolds commonly used for conjugation, with subclass-specific considerations for stability, disulfide architecture, and purification behavior.
- Disulfide-Topology–Driven Conjugation: Programs leveraging native interchain disulfide networks and controlled partial reduction/re-oxidation to achieve targeted modification while maintaining structural integrity.
- Engineered-Cysteine mAbs (Antibody-Centric): Site-enabled monoclonal variants with introduced cysteines or analogous handles on the antibody backbone to support defined attachment while preserving developability attributes.
- Lysine-Accessible mAbs (Antibody-Centric): Monoclonal antibodies qualified for amine-accessible conjugation based on lysine distribution, isoelectric point, and aggregation risk profiles derived from our readiness assessment.
- Glycan-Directed Antibody Formats: Fc-glycan–presenting mAbs suitable for antibody-centric glycan modification workflows, supported by glyco-profiling and comparability analytics.
We unite conjugation chemistry, site strategy, process prototyping, and analytics to generate well-characterized monoclonal antibody conjugates. Platformable methods, stress-tested formulations, and clear documentation reduce risk and accelerate progression to subsequent manufacturing phases. Contact us to tailor a development path aligned to your materials and analytical expectations.
Our products and services are for research use only.
