We offer first-in-human formulation development, and we can supply material for preclinical studies and conduct research-level stability studies. We work with all product types, from small to large molecules, highly viscous products, suspensions, and sensitive formulations. Our goal is to develop a formulation process that will repeatedly achieve defined quality attributes you need for your clinical study, and that can serve as an effective process through commercialization.
Our process engineering team will optimize your formulation, develop an effective and optimized process, and perform scale up studies. We use materials and equipment representative of future GMP manufacturing.
Information gathered during formulation development is shared with our quality control group to allow them a head start in their analytical method feasibility, evaluation, and development.
Wednesday, October 19th | 1PM EST