ADC Bioconjugation

Case study

Development and cGMP manufacturing of a Phase I clinical candidate

Axplora is an expert in ADCs with over 15 years’ experience and more than 200 clinical and commercial cGMP batches produced. We have a multi-scale bioconjugation manufacturing capacity with short-term availability and a fast-track bioconjugation services with seamless transition to clinical supply.

A clinical-stage biopharmaceutical company asked Axplora’s Le Mans site to perform the cGMP manufacture of an Antibody Drug Conjugate (ADC) for the treatment of solid tumors.

Highlights:

  • Process and analytical development followed by cGMP manufacture of a phase I ADC
  • Scale-up from gram to hundred-gram scale
  • A robust process leading to 100% compliant batches