The selection of the most appropriate analytical methods for each ADC depends on the properties of the drug, the linker, and the choice of targeting agent conjugation attachment sites. Our team of QC Scientists have an in-depth understanding of the physicochemical properties of the individual and combined elements of ADCs. Appropriate analytical and bioanalytical methods are selected to monitor the functional attributes of the resulting drug substance.

Our Analytical Capabilities for ADC Manufacturing:

  • Dedicated team to support new method development, method transfers and qualification/validation
  • Complete analytical development packages
  • DS/DP release testing and stability testing
  • Broad range of analytical techniques including:
    • Color, appearance, turbidity
    • pH, osmolality, conductivity
    • Particle testing (visible and subvisible)
    • UV (e.g. for protein concentration)
    • HPLC (e.g. SEC, HIC, RP) and UPLC
    • icIEF (charge heterogeneity)
    • CE (e.g. CE-SDS)
    • Dot Blot/ ELISA
    • Cell-based potency assays, incl. preparation of cell banks
    • Microbiology group: endotoxin, bioburden, identification of microorganisms
  • Raw material testing
  • In-process testing (24/7), PAT
  • Cleaning (swab / rinse by TOC; conductivity)
  • Environmental monitoring
Our global network of development and manufacturing sites in North America, Europe and Asia are equipped with industry leading expertise and will enable you to bring your drug candidate from concept to commercial with one dedicated partner.