The Impact Poor Formulations Have on Drug Development Programs

<span>Before an injectable biologic can be formulated and manufactured, an extensive series of pre-formulation checks are necessary to ensure that developers avoid formulating an unstable, non-viable product&sup1;. Developers must determine whether the injectable biologic will break down within the intended formulation or the manufacturing process. The drug must be thermally stable, possibly resistant to oxidation, tolerate variations in light, and other environmental stresses placed on it during manufacturing and packaging.</span>