Sterile Development Services

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.

Learn more about our Sterile Formulation Development services here

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 talkfuture@pci.com

Talk to us about our world leading sterile development services today.

talkfuture@pci.com

Always growing and continually advancing, we support you from early-stage development through commercialization and beyond, and with 6000+ people in 30 global GMP facilities, we are always near.