Drug product development can be a daunting and expensive process. Biotech companies face many hurdles along the way, including the development and optimization of a scalable, commercially-viable formulation while ensuring safety and efficacy of the final drug product. In order to receive regulatory approval, the manufacturing process and validation methods used to evaluate the drug product performance must be accurate and precise.
At Catalent, our methodologies work toward reducing the overall costs and time it takes to get your product to the clinic. With decades of experience in analytical development, we understand our clients’ needs, the current gene therapy regulatory environment, and have a history of the development and qualification of analytical methods.
The analytical methods created during preclinical development play a major role of any regulatory filing. Robust and reproducible analytical methods can accelerate product and process development, which could lead to an early submission for regulatory approval and eventual product launch.
Analytical capabilities include:
- Gel electrophoresis (Native, SDS-PAGE, agarose)
- HPLC/UPLC assays (SEC/RP/IEX)
- Immunoassays (Western Blot, ELISA)
- Mass Spectrometry
- RT-PCR (Digital, and qPCR)
- Odyssey IR immunoassays
- Dynamic Light Scattering
- Capillary Electrophoresis (SDS-PAGE, IEF)
- CRL Endosafe® nexgen-PTS™ endotoxin assay
- Enzyme assays
- Gas Chromatography
- Transmission Electron Microscopy