Process Development bridges the distance between the research bench and GMP manufacturing for clinical trials. It defines a set of specific objectives to ensure the production of a protein drug will be scalable, reproducible and cost-effective when manufactured under cGMP regulations.

Collectively, Paragon’s upstream and downstream scientists and engineers currently produce and purify 75 to 150 individual proteins per year.

• UPSTREAM DEVELOPMENT – Optimization of all the systems and components of the manufacturing process.
• DOWNSTREAM DEVELOPMENT – Defining the right methods to purify your product.
• ASSAY DEVELOPMENT – Developing the right methods to ensure product quality.
• Analytical Development - Developing and/or qualifying appropriate analytical methods for subsequent cGMP lot release and in-process analysis.

 Contact us for additional information or to request a proposal.