One-Stop Platform for CMC of ADC Drugs
From early conjugation development to GMP manufacturing and analytical release testing—HiLand delivers integrated solutions for Antibody-Drug Conjugates.
Conjugation Process Development
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Chemical Conjugation Technologies
We develop optimized chemical conjugation processes to ensure stability, precise DAR (drug-to-antibody ratio), and batch-to-batch consistency, supporting both preclinical and GMP manufacturing scales.
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Enzyme-Based Conjugation
Our proprietary iLDC (intelligent Ligase-Dependent Conjugation) and iGDC (Glycosyltransferase-Dependent Conjugation) platforms enable site-specific, high-homogeneity ADC production without compromising antibody function.
Benefits:
• Improved ADC uniformity and bioactivity
• Streamlined downstream processing
• Scalable for late-stage development -
Linker-Payload Selection Support
We assist clients in rational selection of linkers and cytotoxic payloads to match pharmacokinetic and therapeutic goals, addressing hydrophobicity, release kinetics, and conjugation efficiency.
Purpose-Built Infrastructure for ADC Development
• Yellow light systems in both development and GMP suites to protect photosensitive ADC payloads
• Single-use glass vessels for flexible scale-up and de-risking development
• Negative-pressure isolators and containment systems to ensure operator safety and prevent cross-contamination during high-potency payload handling
Comprehensive Characterization of ADCs
HiLand offers end-to-end analytical services that support CMC development, release, and stability studies across all ADC modalities.
Average DAR (UV, RP-HPLC, SEC-HPLC, HIC-HPLC)
DAR Distribution (HIC-HPLC, RP-HPLC)
Conjugation Site
Native Mass (SEC-HPLC, HIC-HPLC)
Free Drug
Naked Antibody (D0)
Residual DMSO
Residual DMA
Residual PG
Residual ACN
Endocytosis Activity
By-stander Effect Cell Cycle Arrest
DAR Variants Fraction and Characterization
Comparison of Primary Structure before and after Conjugation
Comparison of High-order Structure before and after Conjugation
Comparison of Fab Related Function before and after Conjugation
Comparison of Fc Related Function before and after Conjugation
ADC Manufacturing Capabilities
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ADC Drug Substance Manufacturing
Our GMP manufacturing suites are equipped for ADC intermediate production at various scales:
• Conjugation capacity: 50L, 200L, 500L (glass, stainless steel, and disposable reactors)
• Capable of supporting up to 150 batches per year
• Chromatography and ultrafiltration equipment (Cytiva, Merck) with single-use consumables
• Built-in controls for cross-contamination and operator safety -
ADC Drug Product Manufacturing
Sterile fill-finish capabilities tailored for ADC formulations (liquid or lyophilized), operated under strict GMP conditions for Phase I-III and commercial supply readiness.
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Integrated Manufacturing Platform
Our end-to-end platform seamlessly integrates conjugation, purification, analytical testing, and final drug product fill-finish—simplifying your CMC pathway and accelerating timelines.
