Case study: Generation of first ADC samples for preclinical studies

Having identified a novel Antibody Drug Conjugate asset, pharmaceutical companies often have the capacity to synthesize R&D samples internally, but few of them have the dedicated facilities to produce larger quantities. They need to find a reliable CDMO partner that can manufacture their ADC sample to support their preclinical development program.

Novasep was approached by a biopharmaceutical company developing a preclinical ADC sample consisting of IgG1 mAb conjugated with a proprietary payload. The customer needed a larger amount of ADC in order to launch a pre-toxicology study.

Highlights:

>  Phase adapted ADC characterization using Novasep's platform methods 
>  Process optimization and scale-up for pre-toxicology study
>  Recommendations for further process & analytical development