Genetic Engineering & Biotechnology News

NOV1 2018

Genetic Engineering & Biotechnology News (GEN) is the world's most widely read biotech publication. It provides the R&D community with critical information on the tools, technologies, and trends that drive the biotech industry.

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6 | SEPTEMBER 1, 2018 | GENengnews.com Ganesh Kumar, Michael Koch, and Gerben Zijlstra, Ph.D. As the biopharmaceutical industry continues to grow at a rapid pace, companies are real- izing that they may need to transform their biomanufacturing networks to respond to changing market dynamics and anticipate cus- tomer requirements. A major factor behind the growth of the biopharmaceutical industry has been the huge and continued success of the monoclonal antibodies segment. Within the industry, however, companies have started to diversify their pipelines, developing products such as antibody-drug conjugates, non-anti- body recombinant proteins, gene therapies, and autologous and allogenic cell therapies. With continued growth of the existing portfolio combined with the diversification of available therapeutics, biopharmaceutical companies are envisioning growth in exist- ing as well as in various emerging markets. As a result, these companies are planning to increase their global reach by manufacturing products within the target market regions. Besides managing growth, product diversifi- cation, and footprint issues, the industry also needs to address four key imperatives: reduce costs, improve flexibility, shorten time to mar- ket, and increase quality/process robustness. Biopharmaceutical companies realize that it will be impossible, in the near term, to have one facility that will fulfill all these market and process demands. Rather, the companies may select from a range of bio- manufacturing scenarios. According to the Biomanufacturing Technology Roadmap, which was issued by the BioPhorum Opera- tions Group (BPOG) in 2017, there are at least five such scenarios: • Large-scale stainless-steel fed-batch operations • Intermediate-scale single-use perfusion plants • Intermediate-scale multiproduct single-use fed-batch facilities • Small-scale portable facilities • Small-scale factories for personalized medicines Single-use and distributed scenarios are more likely if smaller product quantities are re- quired. Stainless-steel and centralized scenarios are more likely if larger quantities are required. It is the authors' opinion, however, that by Single-Use Modules Expedite Total Solutions Single-Use Technologies for Bioprocessing Draw on End-to-End Expertise, Says Sartorius, to Facilitate the Shift to Flexible Biomanufacturing Figure 1. Typical room layout concepts

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