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 ADC Conjugation Case Study Picture

Case study: Successful cGMP conjugation of a novel ADC for phase I clinical trials

 Case Study: Successful cGMP conjugation of a novel ADC for phase 1 clinical trials

 

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.

Highlights:

>  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.

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