Clinical Manufacture

Commercial Manufacture

Drug Product Fill & Finish

Development

Testing

Discovery

Antibody Drug Conjugates

Technologies & Platforms

WuXi greatly simplifies ADC drug development by providing a supply chain and all the necessary preclinical activities in one centralized region (all facilities are within 1-2 hours of each other).

We also provide world-class expertise in conjugation approaches and chemistry and scale-up and manufacture of payload, linker and antibody. In addition full analytical capabilities to characterize an ADC candidate and preclinical programs such as discovery biology, oncology, DMPK and toxicology are also available in-house. We offer a full range of development and manufacturing services both as an integrated package and standalone services. Our comprehensive solutions for ADCs include:

Case Study

In China for Global – 99.5% percent of ADC CMC and preclinical work for an ADC global IND conducted at WuXi

Antibody and payload Conjugation Development & Manufacture

We offer full suite of conjugation chemistry and capabilities  including:

  • Lysine/cysteine
  • Polysaccharide
  • Site-specific conjugation (ThioMab, non-natural amino acid, SmartTag, enzyme-assisted, etc.)
  • Milligram to hundreds of grams of ADC
  • Non-GMP and GMP production of ADC
  • Other biologics conjugation (PEGylation, HESylation, etc.)


Analytical development and characterization of ADCs

We leverage in-house expertise and state-of-the-art analytical equipments to characterize drug candidates at various stages of development, including UV/VIS, HPLC, cIEF, LC-MS. Our analytical assessment of ADCs encompasses all stages of their development, including drug-to-antibody ratio, protein concentration, aggregation, free drug content, PI, peptide mapping, ADC affinity and potency tests.


Formulation Development, Fill & Finish for ADCs

Here is the typical formulation development and fill/finish process for antibody drug conjugates.

ADC Formulation/Fill & Finish Development Elements Studies
ADC Liquid formulation development pH screening Heat stress study
Agitation study
Excipient screening Heat stress study
Freeze-Thaw study
Agitation study
Lyophilization cycle development Heat stress study
Container closure selection Accelerated stability
Long-term stability
Technology Transfer Formulation/Lyophilization process development
ADC fill and finish GMP facility for Phase I/II
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