From clinical to commercial phases
Fast track offer for preclinical studies
One ADC sample with RoA
1-100 mg ADC sample
Platform analytical methods
6 weeks turnaround time
Phase 1 package
First in human clinical trials
100-500 g cGMP scale
Stability studies
Process and analytical development
Phase 2 / 3 package
Clinical and validation Package
Process and analytical validation
Registration batches
BLA regulatory support
Integrated production site
1. Dedicated facilities for payload and conjugation
2. More than 15 years of cGMP manufacturing
3. State of the art bioconjugation facility
4. Excellent regulatory history
Le Mans, France: payload-linker and bioconjugation
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