Bridging the Drug Substance/Drug Product Interface
With the ability to develop both Drug Substance (DS) and Drug product (DP) under the same umbrella, our team enjoys a synergism absent in most CROs. The ability to bridge the DS/DP interface is a major competitive advantage in our ability to shorten development timeline and improve ruggedness of the DP process.
We have technology platforms that can optimize API powder properties, and improve aqueous dissolution as needed. We can effectively address issues affecting formulation early in Phase 1. This fundamental material knowledge forms the basis of our QbD (Quality by Design) approach to improving Phase 2, Phase 3, and commercial processes. Our formulation design and process scale up are also assisted by models such as Physiologically based pharmacokinetic/ biopharmaceutics modeling (PBPK and PBBM) and process unit operation model predictions.
This ability – combined with our dedicated team of specialized Project Managers devoted to responsive customer service – makes us a unique “one stop shop” giving you the best possible experience with the development of your product.