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Biologics / Large Molecule Analytical Services


Customized service that meets the highest standards of quality

We follow appropriate regulatory and industry guidelines for your project during all phases: Preclinical, Phase I/II, Phase III, and commercialization. Having solved many difficult challenges for a myriad of complex biological matrices, we can provide customized bioanalytical (PK and PD) and immunogenicity solutions for the most challenging compounds. Our experience extends across every conceivable therapeutic indication using a wide-range of biological products. We offer a full range of method development, validation, and sample analysis in complex biological matrices using the following technologies:

  • RIA
  • Fluorescence
  • Luminescence
  • Flow cytometry
  • Cell-based neutralization assays
  • Electrochemoluminescence (MSD technology)

Catalent’s expertise extends beyond routine protein analysis to diverse biological products including:

  • Monoclonal antibodies (mAbs)
  • ADCs and bioconjugates
  • Recombinant proteins
  • Fusion Proteins
  • Aptamers
  • Regenerative medicine products
  • Therapeutic viruses
  • Bacterial vaccines