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
We will test and develop full lyophilization cycles at all clinical stages, while reviewing in-depth the thermal profile of your formulated product by Modulated Differential Scanning Calorimetry (mDSC) and Freeze Dry Microscopy (FDM). We will use an iterative approach to optimize the lyophilization cycle with a series of development runs resulting in a pharmaceutically elegant presentation of your product.
Stability indicating analytical methods are critical to process development, and at PCI, we can transfer or develop a stability-indicating analytical method to collect data at each step. To support the development process, we will establish a comprehensive testing plan to observe all aspects of solubility and stability.