Manufacturing ADCs is very complex. Indeed, in-house ADC manufacture requires unique facility design and know-how. This is why an estimated 70 to 80% of the ADC manufacturing market is outsourced. But finding the right partner for ADC supply is not easy!
Novasep was approached by a top 10 pharmaceutical company looking for a reliable partner to help with the manufacture of a cGMP antibody drug conjugate. The ADC was in clinical trial Phase I to treat solid tumors, and the customer required a quantity of ADC within 4 months starting from 100g monoclonal antibody.
> Successful process development and cGMP manufacture of a Phase I ADC, including a chromatography step.
> Fast process transfer from mg to g scale.
> Effective transfer of analytical methods.