Process Development and Scale Up

ADC Development - We offer process development and scale-up through Tox manufacturing and into GMP manufacturing. Our ‘New Process Introduction’ team works closely with the Development team, ensuring the final process transferred into the GMP manufacturing suite is robust. We enjoy a 100% success rate of introducing new projects to GMP developed through our process development group, which supports the client's program through clinical trials and into the commercial stage.

Process Development Activities

  • Preclinical proof of concept studies
  • Formulation development studies
  • Conjugation chemistry optimisation
  • Development and optimization of supporting purification techniques
  • Robustness and process characterization studies

Unparalleled experience

  • Conjugation chemistry experience with non-cleavable, cleavable and enzyme labile linkers
  • Experience with all major drug platforms
    • Auristatins
    • Maytansanoids
    • Duocarmycions
    • Pyrrolobenzodiazepines
    • Other proprietary drugs such as non-cytotoxic small molecule payloads and chelating conjugates for Radio immunotherapy/Imaging
  • Traditional and site-specific conjugation experience
  • Experience in conjugation to IgG1, IgG2, IgG4, engineered antibodies and fragments
  • Capability to work from mg to hundred-gram scales