Stability, Manufacturability, and Patient-Ready Delivery
Robust formulation strategies ensure your therapy is ready for fill-finish and commercial supply. Our science-driven approach stabilizes every molecule from the start, preventing costly downstream rework.
The Foundation of Every Program
Drug Substance Formulation Support
Buffer selection, bulk drug substance stability screening, osmolality, conductivity, and pH optimization across recombinant protein programs.
01
Injectable Drug Product Formulations
Vials, pre-filled syringes, cartridges, and BFS formats — compatibility and stability strategies developed through non-GMP screening before committing to scale.
02
Stability and Accelerated Studies
ICH accelerated and stressed stability studies including forced degradation and stress-testing to characterize degradation pathways and establish formulation confidence ahead of clinical trial initiation and cGMP manufacture.
03
Generic and Biosimilar Pathways
Reverse engineering support for ANDA and 505(b)(2) product pathways, including reference listed drug characterization and formulation comparability assessment.
04
Formulation Science Matched to Your Program
Advance Your Formulation Strategy
Ready to optimize your formulation for stability, scale, and patient impact? Connect with our experts today.