(268) Special challenges for developing sterile biological drug product for intravitreal injection.

Due to the special anatomical structure and physiological barriers of the eye, intravitreal drug delivery is the most effective route for drug delivery to the back of the eye. However, there are special challenges for developing sterile biologic drug products (DP) for intravitreal injection. Here, we will discuss formulation and manufacturing challenges for intravitreal biologic drug product development from an industry perspective.