Antibody Drug Conjugates
WuXi Biologics 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:
- MAb discovery & engineering
- Cell Line Development and Engineering for mAb production
- Discovery chemistry and Medchem services
- Bulk Drug and Drug Product formulation development
- MAb cGMP manufacture up to 2,000 L scale (single-use bioreactors)
- Both mAb , linker and payload process development, characterization & validation
- Linker and payload synthesis and cGMP manufacture (payload production includes HPAPI/toxin production capabilities)
- Antibody and payload conjugation utilizing multiple technologies
- Full in-house assay development and analytical characterization capabilities
- ADC drug product Fill/Finish
- Supporting drug development services (also in-house) that include genomics/biomarker/companion diagnostic development, discovery biology, oncology translational science, DMPK, toxicology, biosafety testing and more!
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:
- 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|
|Excipient screening||Heat stress study|
|Lyophilization cycle development||Heat stress study|
|Container closure selection||Accelerated stability|
|Technology Transfer||Formulation/Lyophilization process development|
|ADC fill and finish||GMP facility for Phase I/II|