Manufacturing With A Highly Potent API For An Ophthalmic Indication

Altasciences was commissioned by a longstanding client to undertake the manufacture of a nano-milled suspension of loteprednol etabonate intermediate, a highly potent active pharmaceutical ingredient (HPAPI) with applications in ophthalmology. HPAPIs, characterized by their potency at approximately 150µm/kg in humans, necessitate specialized handling, safety procedures, and dedicated facilities to mitigate the risk of unintended exposure during production. Loteprednol etabonate, classified as a corticosteroid, demands stringent HPAPI safety protocols for its manufacturing, encompassing operator protection measures.

The study encompassed the entire product development spectrum from research and development to commercialization, underscoring the repeat engagement with the client. The safety program for HPAPIs adhered to traditional industrial hygiene protocols, incorporating meticulous hazard anticipation, event assessment for potential drug exposure, and comprehensive control measures for all identified exposure events. This approach aimed to ensure the secure and effective manufacturing of the nano-milled suspension, emphasizing Altasciences' commitment to maintaining the highest standards in the handling of highly potent pharmaceutical ingredients throughout the drug development process.