Analytical Development
OVERVIEW
Comprehensive Analytical Techniques
Our 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.
COMPREHENSIVE ANALYTICAL TECHNIQUES
- 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 expert analytical development solutions, accelerating programs towards and through the clinic, and ultimately to market. Additionally, Catalent’s site in Kansas City, Missouri, US, serves as an analytical center of excellence supporting nearly all large molecule types with both integrated or standalone services. With over 30 years of experience, our seasoned experts deliver tailored, phase-based solutions, regardless of complexity, scale, or timeline.
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