We have the capability to deliver at any stage of your sterile fill-finish project with true expertise and to tight timelines, managing solubility and stability challenges as well as assisting with challenging formulation processes.
Our Sterile Formulation Development Services
Based on the results of an in-depth Process Risk Assessment of your current manufacturing process, we will work with you to determine the Critical Process Parameters (CPPs). We will design an experimental plan to investigate and characterize the CPPs. Using the Quality by Design (QbD) approach, we can develop a formulation that will increase product solubility. If an aqueous formulation does not yield the desired concentration, we can use complexing agents such as cyclodextrins or an organic solvent formulation, emulsion or suspension.
Our Lyophilization Cycle Development Services
Our dedicated team of specialists will be happy to discuss our Sterile Development Services with you. Contact us on +1 779-208-1819 (US) or +44 1495 711 222 (UK/EU) or email email@example.com
Our development & manufacturing services
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