We provide end-to-end laboratory support within the Pharmaceutical Development & Manufacturing continuum, advancing through Drug Substance Development to specialized ADC programs. Our focus is rigorous experimentation, platformable chemistries, and scale-aware methods that translate seamlessly from bench feasibility to manufacturing enablement.
Overview of Antibody–Drug Conjugate (ADC) Development
ADC development integrates three tightly coupled components—antibody, linker, and payload—into a single, well-characterized macromolecule. Successful programs align conjugation strategy with molecular design, analytical traceability, and manufacturability. We emphasize orthogonal analytics (LC–MS, HIC, SEC, CE-SDS), robust impurity profiling, and stability-indicating methods to control heterogeneity and aggregation. Process prototypes are designed to be scalable, supporting site-specific or stochastic coupling while maintaining consistent drug-to-antibody ratio (DAR) and biophysical properties that enable purification, formulation screening, and reference standard establishment.
Our Services
We deliver a coherent suite services: monoclonal antibody conjugate development, bispecific ADC development, and linker–payload development. Each service is executed under study plans, platform SOPs, and fit-for-purpose quality frameworks tailored to pre-manufacturing laboratories.
Monoclonal Antibody Conjugate Development
We establish conjugation-readiness of monoclonal antibodies and deliver bench-to-pilot process prototypes. Typical scopes include sequence and variant assessment, engineered cysteine/lysine mapping, and evaluation of site-specific vs. conventional chemistries. We screen coupling conditions (pH, reductant control, solvent windows), optimize DAR targets, and mitigate off-pathway species by fine-tuning reducing equivalents and quench steps. Downstream, we design capture/polish trains suited to ADC hydrophobicity—frequently combining precipitation windows, mixed-mode or reverse-phase steps, and gentle buffer systems to preserve higher-order structure.
Bispecific ADC Development
We address the added architectural and biophysical complexity of bispecific scaffolds. Upstream, we deconvolute chain pairing and evaluate knob-into-hole, CrossMab-like, common-light chain, or Fc-engineering formats for conjugation compatibility. We balance epitope geometry with payload placement to preserve avidity while controlling hydrophobic load. Our studies compare single-site vs. dual-site payload strategies and assess whether orthogonal handles are beneficial for distribution of DAR across the two arms. We build analytics that resolve chain-level identities, monitor mispairing, and quantify species-specific payload occupancy. Process development focuses on selective reduction/alkylation regimes, orthogonal purification for mispaired species, and formulation micro-screening to attenuate self-association.
Linker–Payload Development
We design and optimize linker–payloads that define release mechanics, catabolite identity, and manufacturability. Workstreams include cleavable vs. non-cleavable architecture selection, spacer tuning to modulate hydrophobicity, and incorporation of analytical "signatures" that accelerate LC–MS readouts. We establish compatible activation chemistries, impurity clearance strategies, and stability envelopes for the isolated linker–payload and the assembled ADC. Where appropriate, we evaluate masked or prodrug-like elements to temper hydrophobic hotspots. For dual-payload concepts, we implement orthogonal triggers and coupling handles, ensuring separation of reaction pathways and simplifying analytics.
We integrate antibody engineering, bispecific architecture control, and linker–payload optimization into a laboratory-centric ADC offering. Our platform methods, analytics, and scale-aware prototypes are designed to de-risk transitions into manufacturing. Contact us to configure a study plan.
Frequently Asked Questions
Q1: How do you control DAR and heterogeneity during early development?
We co-optimize reduction degree, reagent stoichiometry, and quench timing while using HIC-DAR, intact/subunit MS, and free-drug assays to close the loop. Process windows are parameterized to maintain narrow DAR distributions and suppress high-DAR aggregates.
Q2: What analytics package do you recommend for a first-pass ADC prototype?
A practical core set includes intact mass, subunit mapping, peptide mapping for modification loci, HIC for DAR and species resolution, SEC for size variants, CE-SDS for purity, and targeted LC–MS for linker–payload catabolites. This set is stability-indicating and scalable.
Q3: How do linker–payload choices impact downstream purification and formulation?
Spacer length, charge, and cleavable motifs affect hydrophobicity and colloidal stability. We co-design the purification train—often adding mixed-mode options—and run micro-formulation screens to prevent aggregation while preserving release characteristics and analytical traceability.
Our products and services are for research use only.
