Fact Sheet: Aptuit INDiGO™

Once again, Aptuit is taking a bold, new step to engineer a better drug development process. Aptuit’s Fast-to-IND service will substantially reduce time to first-in-man clinical trials while improving consistency of results and product knowledge, the two backbones of quality.

Fast-to-IND reduces time from API to IND submission to as little as 26 weeks for appropriate compounds. These reductions are achieved by merging traditional preformulation, drug substance, drug product, clinical supplies and analytical silos into a single unit managed by a veteran, dedicated project manager and staffed by professionals with experience spanning the development process.

The Fast-to-IND approach is based on a novel discipline we call development science, and centers on four primary elements:

• Eliminating artificial barriers between drug substance (API) and drug product development, merging these into a single track, called clinical supplies. This approach streamlines the pre-IND process down to only three development tracks: (a) Preclinical toxicology; (b) Clinical supplies; and (c) IND preparation. These tracks operate in parallel to reduce time to clinical trials.
• Modern approaches such as amorphous dispersions to increase the solubility and bioavailability of the test compound.
• Utilizing quality-by-design strategies in the earliest stages and throughout the development cycle. This will enable the facile implementation of such strategies for successful drug candidates at each stage.
• Establishing information for patent filings even during this early timeframe and maintaining the seamlessness and integrity of data throughout.