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Analytical Development

Three beakers with orange, blue and clear liquid in themOur analytical experts have experience with a broad range of large molecules. We can develop methods at any stage of the product development process. With up-to-date knowledge of regulatory requirements and technologies, our scientific staff can provide well-developed strategies to guide, customize, and execute the method development plan in an efficient manner to meet requirements and timelines.

Our team can also provide method optimization in response to manufacturing changes, formulation changes, method robustness or to establish a more optimal method.

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  • In vitro bioassay determination of biopotency
  • Binding assays
    • Binding assay automation (robotics)
    • Potency assays
    • Quantitative assays
    • Radio assays
  • Molecular Biology
    • PCR/qPCR
    • Agarose gel analyses
    • DNA sequencing (automated)
  • Physical Testing
    • pH
    • Osmolality
    • Density
    • Viscosity
    • Visual appearance
    • Visible particles
    • Sub-visible particles
  • Electrophoretic separation analyses
    • Capillary electrophoresis
    • Slab gel electrophoresis
  • Extended characterization of CQAs/PQAs
  • Higher order structure
    • Dynamic light scattering (DLS)
    • Circular dichroism (CD)
    • Fourier-transform infrared spectroscopy (FTIR)
  • Stability testing and storage
  • Compendial testing according to USP, EP, JP, etc.
  • Microbiology
    • Sterility
    • Bioburden
    • Endotoxins

We also offer GLP method development, validation and analysis including:

  • Cell-based bioassays and ELISAs
  • Aggregation studies

Catalent Biologics’ global network provides integrated solutions for analytical, accelerating programs towards and through the clinic, and ultimately to market. In addition, our facilities in Kansas City, Missouri, US and Research Triangle Park (RTP), North Carolia, US, are Catalent’s Centers-of-Excellence for large molecule standalone analytical services. With more than 30 years of experience, they have one of the most diverse analytical service offerings, and routinely handles stand-alone and integrated analytical projects.

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