Sterile Formulation Strategies To Shorten Timelines For First-In-Human Studies

By Christy Eatmon, Global SME, Thermo Fisher Scientific

In the long and costly path to market, early development decisions to prepare a molecule for its clinical journey are among the most critical. Creating a complex formulation from the start can potentially add challenges and bottlenecks that may slow your path to market in later phases. On the other hand, moving too quickly and not gathering sufficient data along the way can make expediting timelines a challenge. Additionally, sterile injectable drugs sometimes call for unique manufacturing and packaging requirements that must be taken into consideration during formulation development. That is why it is important to adopt strategies that create simple but stable formulations for your sterile injectable, thereby establishing a solid foundation for the entire life cycle of your product.