Ophthalmic Product Development From molecule to market, Unither supports every stage of ophthalmic product development. Our integrated CDMO model accelerates your project while ensuring compliance, sterility, and patient-centered design. Our ophthalmic development teams work closely with partners to design robust formulations, validate analytical methods, and secure scalable aseptic manufacturing. The process follows a clear sequence: Preformulation: API characterization, solubility optimization, compatibility and early stability. Analytical development: assays, degradation, sterility and microbiological controls. Formulation: QbD and DoE-based design of solutions, gels, emulsions, and nanosystems. Sterilization: steam impact, filtration, and filterability studies. Container/contents interactions: stressed, extractables and leachables studies. Scale-up: process robustness, validation, cleaning verification, and clinical batches. Industrialization: small commercial batches, full validation, and ICH stability. Each phase builds on the previous one, ensuring efficiency, traceability, and quality from the first idea to market launch. This structured yet flexible approach allows Unither to adapt to your molecule and market requirements—fast, safe, and compliant.
