Paragon’s scientists excel in the development and implementation of in-process and release assays for biologic therapeutic manufacture. 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 the approval of regulatory bodies, the manufacturing process and validation methods used to evaluate the drug product performance must be accurate and precise.
Paragon’s methodologies work towards reducing the overall costs and time it takes to get your product to the clinic. With more than 27 years of experience in analytical development, Paragon understands our client’s needs, the current regulatory environment and have a history of the development and qualification of analytical methods. We utilize key, audited subcontractors for select specialized analysis when services are more cost-effectively outsourced.
The analytical methods created during pre-clinical 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.
Our processes for analytical development includes:
- Assessing the project scope
- Evaluating the current protocol for the drug substance (API)
- Providing a complete robust quote
- Assessing pre‐existing production to develop and optimize new formulations
- Transferring, developing and/or qualifying analytical methods
- Performing formal stability tests to assess final candidates
- Qualifying methods to evaluate robustness, accuracy, linearity, and specificity
- Adhering to US and EU regulatory standards
- 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-PTS endotoxin assay
- Enzyme assays
- Gas chromatography
- Transmission electron microscopy