To develop the science and engineering methods for designing, scaling, optimizing and controlling dosage form design and relevant manufacturing processes. We are committed to developing a scientific foundation for the optimal design of structured organic particulate systems (i.e., active pharmaceutical ingredients (API) dispersed in an organic matrix). We actively apply the concepts of Quality by Design (QbD), an FDA initiative that has broad implications to overhaul the approach that pharmaceutical manufacturers use in facility design and operation, materials properties analysis and process control. Teams of qualified researchers at C-SOPS use cutting-edge pharmaceutical research to address fundamental scientific challenges and to apply this knowledge to develop and optimize new manufacturing methods. C-SOPS has the ability to support manufacturing development from concept to qualification.
In the changing global pharmaceutical market, competition, regulation, and economic conditions are driving the need to introduce new processes and products. C-SOPS helps manufacturers overcome “regulatory risk” by using good science and research to promote and maintain high standards of product safety and efficacy. The results can lead to science-based, higher quality and lower process risk, facilitating quicker approval by the FDA and other regulatory agencies.
Fundamental Science Research
At C-SOPS, we focus on understanding basic aspects of pharmaceutical and manufacturing science where lack of knowledge has been a fundamental barrier to the development of and manufacture of newer dosage forms. These programs range from the formation and characterization of particles and particulate dispersions to the science needed for the development of manufacturing systems operating under closed loop control.