Biologics / Large Molecule Analytical Services

PRE-CLINICAL AND CLINICAL GLP STUDIES

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:

• ELISA
• 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