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.
Want to learn more about fill finish? We have several resources to help guide you in your drug production process.
Download our free guide! This document offers an introductory overview to the fill finish process, which teams are involved, and key differences in filling environments and equipment commonly employed at CDMOs.