BioPharm June eBook: Single-Use Systems

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Page 41 of 46 June 2018 BioPharm International eBook 41 Single-Use Systems Bioreactors TRAIMAK/ Comparing the Supply Lifecycle of Bioreactors Understanding differences in bioreactor lifecycle, design space, and product platforms is important for selecting a bioreactor type. W hen it comes to biologic drug man- ufacturing, quality, specificity, effi- cacy, and reliable supply top the list of objectives. To achieve these objec- tives, effective manufacturing opera- tions require unified focus and close cooperation from all functional stakeholders. Innovation and change in areas such as process science, technology, regulatory opinion, and market conditions constantly influence business adaptation, survival, and growth. Over the past 20 years or so, the industrialization of cell culture processes, the acceptance of biosimi- lars, patent expirations, mergers and acquisitions, and the emergence of single-use technologies have driven innovation and instigated change. In consideration of these factors and others, adaptations to conventional biomanufacturing paradigms have developed. The origins of the biopharmaceutical manufacturing industry were based largely on a single-product, single- plant paradigm. Multiple, similar products from one plant were possible. These conventional, legacy biomanufac- turing models typically used custom-built stainless-steel bioreactors. In the past 15 years, however, due in part to innovations sparked by GE's rocking single-use bioreactor, single-use stirred-tank bioreactors have emerged(1). With titer improvement, the need for manufacturing flexibility, and a changing regulatory climate, single-use bioreac- tors are being used in hybrid facilities as seed systems for KENNETH CLAPP Kenneth Clapp is a senior manager at GE Healthcare.

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