Pharmaceutical Process Development
We know how to get you where you need to be at any stage of your aseptic fill finish project. If you have a tight timeline, solubility issues, stability issues, a difficult formulation process… or all of the above, LSNE has the flexibility to help you reach your formulation or lyophilization process development milestone whether it is getting your product into the clinic or finalizing an elegant commercial presentation.
Based on the results of an in-depth Process Risk Assessment of your current manufacturing process, LSNE will work with you to determine the Critical Process Parameters (CPPs). An experimental plan will be designed with you to investigate and characterize the CPPs. Using Quality by Design, we can develop a formulation to increase your product’s solubility. If an aqueous formulation will not yield the desired concentration, we can explore using complexing agents like cyclodextrins or an organic solvent formulation, emulsion or suspension.
Lyophilization Process Development
Does your product not have the stability needed to enter the clinic?
LSNE can put its years of customized lyophilization development programs to the test and develop robust lyophilization cycles for all clinical stages. We start with a deep understanding of the thermal profile of your formulated product by using Modulated Differential Scanning Calorimetry (mDSC) and Freeze Dry Microscopy (FDM). Then we take an iterative approach to optimize the lyophilization cycle through a series of development runs that will culminate in a pharmaceutically elegant presentation of your product.
Stability indicating analytical methods are critical to process development. LSNE can transfer or develop a stability indicating analytical method to gather important data each step of the way. To support the development process, we will establish a comprehensive testing plan to ensure we are observing all aspects of solubility and stability.