“On the process side, our goal is to build and incorporate new models and tools into our process development workflow. What this means is that we will be able to better predict lyophilization cycle times and conditions both from first principles and from the extensive experience we have. Our aim is to accurately forecast performance not only at small scale, where products may have little or no history, but also during scale-up to full production batches.
On the formulation side, we are specifically working to create lyopastilles that can meet any target product profile. This ranges from rapidly-dissolving ODTs to modified-release mucoadhesive formulations that can accommodate any dose and any type of molecule desired to be delivered orally. Currently, we’re building our tool chest to address all types of projects, both from a material and expertise perspective.
Ultimately, our goal is to integrate formulation and process development into a unified approach. For example, the ability to measure and model the impact of both freezing rates and formulation will enable us to target specific dissolution rates for many compounds. This level of control will allow us to engineer Lyopastilles that can meet the needs of any client looking to create a lyophilized dosage form.”