Our extensive process development experience will ensure that your process technology is translated into a robust, scalable, economic and validatable manufacturing process quickly. Whether for clinical or commercial production, we can help your organization:

• Plan bench-top process development for recombinant proteins, monoclonal antibodies and vaccines produced in bacterial fermentations, mammalian cell culture or eggs.
• Incorporate scalable unit operations into your process.
• Scale-up the production process to produce clinical supplies.
• Ensure your process meets all relevant regulatory requirements.
• Define and execute formulation development, in-process testing, bulk and final product testing and release.
• Coordinate technology transfer of a scaled-up cGMP manufacturing process.
• Develop and deliver on a defined project timeline.