The final step(s) in an API process is/are the most critical for a robust and successful process. Optimizing these steps (including salt formation and/or crystal form isolation) before the first GMP campaign will ensure scale-ability with confidence in impurity rejection, API form, and avoidance of time delays. This optimization requires in-depth understanding of solid-state principles combined with sound process chemistry and engineering principles.
VxP Pharma is the leading solid state research lab in the world. We specialize in developing robust and productive final step processes with an emphasis on solid state understanding. Simultaneously, we have expanded our process and analytical research team to simultaneously work on early steps in your API process while we finalize the end-game. Then we can fit the pieces of the puzzle and provide GMP material of the right form, purity profile, particle characteristics all in a robust process that has visibility into metric ton scale.
The goal of this drug discovery phase is to maintain superior properties in lead compounds while improving on deficiencies in the lead structure. The quality of the hit-to-lead starting point and the research team’s experience are the key determinants of a successful outcome of this phase of work.
Quality testing for chemical affinity, permeation, and pharmacokinetic (PK) properties affecting the overall bioavailability of the lead compound are optimized by our medicinal chemists who have extensive experience in this critical stage of development. Other established testing in this stage, including high-dose pharmacology, pharmacodynamic (PD) studies, dose linearity, repeat dosing PK, and metabolic profiling should be completed by the end of this stage as well.
In addition, the researchers can optimize the activity profile of your lead compound by creating a library of related compounds through parallel synthesis, giving you the benefit of multiple other potential leads. As part of this process, consideration will be given to the properties of each compound as to whether there is any identifiable structure-activity relationships (SAR) found throughout the cluster.
The complexity and shear size of the testing work-load in this stage of discovery can be daunting, but with the help of the medicinal chemists the path to a stable and profitable lead molecule or series can be successfully achieved in an effective, time-efficient methodology.
The state-of-the-art labs are staffed by some of the best trained and most experienced subject matter experts in the field.