Our scientists are highly skilled in the design and synthesis of a variety of toxins and linkers, such as the mechanistically diverse MMAE/MMAF, Maytansine derivatives, Duocarmycin, Nemorubicin, and pyrrolobenzodiazepines. We purify and characterize ADCs using state-of-the-art technologies. A dedicated, certified, high-potency lab is fully operational and capable of handling APIs with OEL < 1 ug/m3 at scale up to 50 grams.
Our biologics team is able to develop antibodoes from scratch using Phage display or Hybridoma methods. The CMC team has GMP compliance antibody production and fill-finish capacity up to 400 grams. The ADC team has early discovery, optimization, and evaluation capacity using different antibody, linker, and toxin combinations. The GLP CMC facility has the production capacity for producing up to 40 grams.
All ADC-related functions and developments are fully supported with a well-equipped, state-of-the-art analytical facility. The ADC team has also worked with many pharma and biotech companies on novel toxins to create novel ADCs with additional mechanisms of action.
Flexible Early Clinical Development
- Antibody development from antigen generation until humanized antibody production cell line generation
- Customized toxin/linker design and synthesis
- Preparation of ADC sample panels using a variety of linker/toxin/mAb combinations
- ADC scale-up process development and formulation development
- Dedicated ADC R&D teams ready for new projects and drop-ins
- GLP ADC production up to 40 grams
- DMPK and in vivo pharmacology team support IND-enabling test
ADC Analytical Services
- Complete analytical development packages with mAb/ADC harmonization
- Bioassay implementation
- ADC release and stability testing
- Pharmacology, PK/PD & Exploratory Toxicity
- Dedicated ADC QC teams to support new method development or method transfers