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Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING EBOOK 2021 49 Operations S terile fill/finish manufacturing is expected to experience significant growth over the coming years, with some market research analysts predicting the field to be worth $12.1 billion by 2025 (1). Expanded drug development pipe- lines, incorporating more complex, large-molecule products and therapies that require sterile production, form part of the driving force for this rising demand for fill/finish services. Ophthalmic therapeutics, in particular, require heightened exper- tise due to the fact that they are administered to the eyes, which are extremely sensitive and important organs. To learn more about the intricacies of sterile fill/finish manufacturing, specifically pertain- ing to ophthalmics, Pharmaceutical Technology spoke with Daniel Kehl, chief executive officer at swissfillon—a fill/finish specialist based in Switzerland. Primary driver PharmTech: How important is sterile fill/finish when dealing with ophthalmic therapeutics and biological products? Kehl (swissfillon): The primary driver for fill/finish is providing a sterile dosage form (usually a syringe or vial) that allows a drug sub- stance to be distributed and administered to a patient. Because bio- logics and ophthalmics are sensitive to temperature, it is not possible to carry out thermal sterilization, so, in order to guarantee sterility, we have to rely on sterile filtration of the drug into the primary pack- aging as well as final sterilization of the packaging via ethylene oxide (EtO), vapor hydrogene peroxide (VHP) or nitrogen dioxide (NO 2 ). In the case of ophthalmics, latest generation fill/finish technologies Eyeing Up Success in Fill/Finish Felicity Thomas Certain therapeutics, such as ophthalmics, must be provided as a sterile dosage form but can pose fill/finish challenges due to the small batch sizes required and the fact that the products used are difficult to fill and of high value. F8STUDIO - STOCK.ADOBE.COM