BioPharm June eBook: Single-Use Systems

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46 BioPharm International eBook June 2018 Single-Use Systems Bioreactors Thorough understanding and proper planning can result in a single-use bioreactor capable of producing mul- tiple drug products over many years. Unlike conventional stainless- steel systems, where most, if not all, buyer-supplier relationships end with capital equipment acceptance or turn-over, single-use bioreac- tor platforms and the bioreactor bag in particular establish a per- sistent level of engagement. New, more durable stakeholder relation- ships are required to maintain the technical, commercial, and quality aspects of the disposable bioreactor bag lifecycle. Mutual recognition of each party's contribution to a successful outcome facilitates the breakdown of pre-existing barriers to communication and informa- tion sharing. Open, two-way com- munication offers an opportunity to improve operational efficiency through effective lifecycle manage- ment for both buyer and supplier. Covering more than just quanti- ties and delivery, supply agreements may be used to incorporate other identified success factors, such as cha nge ma nagement a nd inc i- dent investigation, into a guiding enforcement document. In premanufacturing scales, glass and stainless-steel bioreactor use is widespread and often the norm. Other than process performance- related and technology selection considerations, these smaller-scale bioreactors often differ substantially from the larger, stainless-steel pro- duction-scale units in a number of ways. Differences include: equipment size, complexity, automation (mea- surement and control), and ERP data and document management. These attributes are associated with "fitting," or integrating production bioreactors into the facility. Customized stain- less-steel bioreactors, using the con- ventional approach, are specified to custom fit each time. Discrete, one-off designs make it impractical for suppliers to develop produc t plat for ms. Absence of platform-based standard products perpetuates a lifecycle in which resources and time are repeatedly expended to re-invent the prover- bial "wheel" with each capacity expansion. Single-use bioreactor platforms offer an opportunity to improve this process. Single-use bioreactor platforms offer consistency of form, "facil- ity fit," and function. From process development to production scale, single-use bioreactors share design, materials, components, measure- ment and control, documentation, and data. Also, these product platforms inherently alig n hardware and bag de sig n spac e s . T he r e for e, p r e m a n u f a c t u r i n g s c a l e s a r e usef u l i n sor t i ng out mater ia l biocompat ibi l it y, process f lu id ma nagement st rateg ies, opera- tor guidance, and data handling/ integration methods. T he e x p a n s e o f t he d e s i g n space(s) and the platform's mod- ularity (8) may be used to "con- figure" instead of custom build a single-use bioreactor that fits the needs of a particular biomanu- fac t u rer 's operat ion a nd fac i l- ity. In the search for new, more cost-efficient, f lexible biomanu- facturing paradigms, single-use bioreactor platforms represent a decisive enabling technolog y— f rom old: cha nge t he process, change the facility; to new: change the process, change the bag. REFERENCES 1. K. Clapp, "The Great Debate: Stainless Steel Versus Single Use," https:// the-great-debate-stainless-steel-versus- single-use/, accessed April 4, 2018. 2. T. Deeks, BioPharm Asia (May/June), 32-36 (2017). 3. T. Deeks and K. Clapp, "Single-Use & Stainless Steel Bioreactors: Quality Factors for Consideration When Selecting a Suitable System," https://biopharma- steel-bioreactors-quality-factors- consideration-selecting-suitable-system, Webinar by Biopharma Asia, Nov. 8, 2017. 4. K.P. Clapp, A. Castan, and E.K. Lindskog, "Upstream Processing Equipment," Biopharmaceutical Processing in Development, Design, and Implementation of Manufacturing, Processes, G. Jagschies, E.K. Lindskog, K. Lacki, P. Galliher, Eds. (Elsevier, Amsterdam, 1st ed., 2017), pp. 457-476. 5. G. Gadea-Lopez and J. Maguire, BioPharma Asia (November/December), 6-10 (2016). 6. G. Gadea-Lopez, J. Maguire, M. Maselli, and Kenneth Clapp, "Single Use Systems in Biologics Manufacturing and their Impact on Operational Technology," single-use-systems-in-biologics- manufacturing-and-their-impact-on- operational-technology, Webinar by BioPharma Asia, April 4, 2017. 7. K. Clapp, "Single-Use Operational Excellence Explained: Effective Lifecycle Management," www.pharmasalmanac. com/articles/single-use-operational- excellence-explained-effective-lifecycle- management, Webinar by Pharma's Almanac, Oct. 26, 2017. 8. K Clapp, "Automation Solutions Supporting Process Development and Biologics Manufacturing," https:// automation-solutions-supporting- process-development-and-biologics- manufacturing, Webinar by the Medicine Maker, Oct. 10, 2017. BP Ad Index Advertiser Page No DISTEK INC Cover Tip LEE INDUSTRIES INC 5 PDA 19 PHRMA 25 WUXI APP TEC 2

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