Formulation and Quality – Biomolecular
Intraocular delivery of biologics presents challenges due to their complete inability to cross the blood-retinal barrier and unpredictable PK in vitreous. Biologics for intraocular treatment are therefore mainly delivered as intravitreal (IVT) injection to achieve therapeutic concentrations of biologics in the vitreous humor (VH) and retina. Besides clinical challenges, a number of technical challenges, such as but not limited to, viscosity, dose volume, microbiological safety as well as particulate matter are critical to successful development of an IVT product. Health authorities have acknowledged and differentiated intraocular products over topical ocular products, intravenous or subcutaneous products with specific requirements; however, information and understand of technical requirements are still limited. The seminar will review our current understanding of the state of the art in this field, from the biology, formulation and delivery perspective.