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Page 16 of 26 June 2019 BioPharm International eBook 17 Single-Use Systems Buffers • Buffer concentrates with auto- mated buffer dilution are cost comp et it ive at fac i l it y con- sumption rates of up to 4 mil- lion L/yr. BioPharm: How do e s si n g le - use technolog y used in bu f fer preparation promote continuous bioprocessing? Bulpin: Single-use technologies provide enhanced process inten- sification. Many biopharmaceuti- cal manufacturers are turning to single-use technologies for their flexibility, cost savings, speed, and reduced risk. Flexibility is highly beneficial to multiproduct facili- ties that produce a variety of dif- ferent products at different scales. Single-use also helps lower costs by reducing plant footprints and upf ront capital spend, as com- pared to traditional stainless-steel facilities. A third benefit is speed. With single-use, there is no need for clea n-in-place or stea m-in- place and no need for validation of these operations, which greatly reduces the time it takes to get a facility up and running. Finally, single-use reduces a drug manu- facturers risk profile. As the name suggests, once you use the prod- uct, you discard it and install a brand-new sterilized assembly, so the risk of product carry-over is eliminated. In addition, due to the closed nature of single-use, you have better biological and viral contamination control. PUSH FOR INNOVATIVE SOLUTIONS BioPharm: H o w wo u l d a b u f- f e r p r e p a r a t i o n s y s t e m l i k e BioCont inuu m Bu f fer Deliver y Platform revolutionize the way buffers are prepared, and what does that mean for the industry? Bulpin: T here is a sig nif icant demand from the industry to move toward outsourced buffer prepa- ration. We estimate that intensi- fied buffer preparation within the industry will increase from 7–47% by 2023. This manufacturing evolution brings with it process challenges. Manufacturers are looking to sup- pliers for integrated solutions as they think holistically about their process and visualize future scale up. The industry is buzzing about continuous processing because it will have a significant impact on how drug makers bring therapies to market with the intent of deliv- ering them to patients faster and more cost-effectively than before. The industr y is moving toward intensified, connected, and con- tinuous bioprocessing. M i l l i p o r e S i g m a h a s d e e p - rooted industr y experience and application exper tise that dr ug m a nu f ac t u r e r s r e ly on world - wide. With both single-use and regulatory experts based in dif- fe re nt ge og raph ies a rou nd t he world, we of fe r mor e t ha n 10 years of single-use design, engi- neering, quality, and validation expertise as well as a network of M L ab Customer Collaboration C enter s, wh ic h of fer sc ient ists and engineers a non-GMP envi- ronment to test, optimize, ana- ly ze, a nd t roublesho ot i n rea l scale without the strict require- ments of their ow n production facilities. In addition, we actively e n g a g e i n d i f f e r e nt i n d u s t r y consor t iu ms t hat a re c ur rent ly defining the standards associated with single-use adoption. We w ill continue to collabo - rate with drug manufacturers, as well as other single-use suppli- ers, to standardize test methods for single-use systems and to ease the implementation and regulatory filing challenges associated with single-use. REFERENCES 1. GE Healthcare, "Buffer Management Solutions for Large-Scale Biomanufacturing," White Paper, KA451051017WP, 2017. 2. MilliporeSigma, "MilliporeSigma Elevates its BioContinuum Platform Strategy to Deliver 'ContiGuous' Bioprocessing," Press Release, April 2, 2019. BP More on buffers For more on buffers, read these articles on • The Importance of Buffers in Downstream Processing • Behind the Scenes with Buffers • MilliporeSigma Unveils Buffer Delivery Component for BioContinuum Platform at INTERPHEX 2019 interphex-2019 • A Closer Look at Automated In-Line Dilution

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