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BIO INNOVATION NOTES these as significantly more serious concerns with perfusion than with batch-fed systems — even though this is often not the case. In fact, perfusion/continuous processing now tends to be generally less complex, less prone to contamination, and more readily scalable than fed-batch methods. These fears and growing pains include addressing concerns of regulators who have yet to fully understand some aspects of this technology, such as defining lots/batches and doing QA/QC with continuously manufactured products. THE FUTURE OF NEW PERFUSION TECHNOLOGIES New perfusion technologies may ultimately mature and revolutionize bioprocessing. For example, a 50 L bioreactor with cells bound to capillary fibers in development by FiberCell will be able to manufacture the same quantity of product, at better quality, than a 1,000 to 5,000 L bioreactor over the same time period using the same amount of culture media. Similar bioreactors were in common use for hybridoma (non-recombinant monoclonal antibodies) manufacture back in the 1980s. So increasing adoption in coming years will actually be nothing new. Much of the adoption of perfusion will be associated with single-use equipment, particularly as current products being developed by single-use manufacture graduate to commercial manufacture. Figure 1 Likelihood Of Implementing Bioreactor (By Type) 42.0% Fed-batch Bioreactors, Single-use 65.6% 58.0% Fed-batch Bioreactors, Stainless Steel 39.7% 25.2% Perfusion Bioreactors, Single-use 32.1% 22.1% 22.9% Concentrated Fed-Batch Bioreactors Commercial Clinical 18.3% Perfusion Bioreactors, Stainless steel 13.0% Source: 10th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production, BioPlan Associates, Inc., April 2013. Survey Methodology: The BioPlan annual survey of biopharmaceutical manufacturers yields a composite view and trend analysis from over 300 responsible individuals at biopharmaceutical manufacturers and CMOs in 29 countries. The survey included over 150 direct suppliers of materials, services, and equipment to this industry. This year's study covers such issues as new product needs, facility budget changes, current capacity, future capacity constraints, expansions, use of disposables, budgets in disposables, trends in downstream purification, quality management and control, hiring issues, and employment. The quantitative trend analysis provides details and comparisons of production by biotherapeutic developers and CMOs. It also evaluates trends over time and assesses differences in the world's major markets in the U.S. and Europe. If you want to learn more about the report, please go to bioplanassociates.com. 18 LifeScienceLeader.com February 2014