BioPharm June eBook: Single-Use Systems

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Page 13 of 46 June 2018 BioPharm International eBook 13 Dmitry Kalinovsky/ Single-Use Boosts Fill/Finish in Commercial Biomanufacturing Single-use technologies have become increasingly prevalent in final fill/finish operations for biologics. T he increasing number of biologic drugs in development is driving the need for more effi- cient and cost-effective manufacturing technol- ogies, including in single-use technologies for final fill/finish. Single-use technologies have become increasingly prevalent in fill/finish as a result of industry demand. BioPharm International spoke to BJ Hull, vice-president and general manager (Camden), Emergent BioSolutions; Sara Bell, senior marketing manager, Single-use Solutions, MilliporeSigma, a business of Merck KGaA, Darmstadt, Germany; and Claus Feussner, PhD, senior vice-president Vetter Development Service, Vetter Pharma-Fertigung, on the adoption, benefits, and challenges of single-use sys- tems in final fill/finish manufacturing. SINGLE-USE ADOPTION BioPharm: How much of biologic fill/finish involves sin- gle-use components, technology, and equipment, and is adoption more prevalent in the fill/finish stage than in the bioprocessing stages preceding it? Hull (Emergent BioSolutions): As a fill/finish contract man- ufacturing organization (CMO), there are parts of the equipment train that are single-use for every product we fill. Filtration and fill assemblies, filling needles, filters, and, in many cases, the formulation vessels and equipment as FELIZA MIRASOL Single-Use Systems Fill/Finish

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