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6 BioPharm International eBook June 2019 Single-Use Systems Manufacturing " T he s e s y ste m s of fe r mu lt iple b e ne f it s t hat ra nge f rom sub - sta nt ia l ly faster t i me to estab - l i s h m a n u f a c t u r i n g c a p a c i t y a nd i nc r e a s e d m a nu f a c t u r i n g f lex ibilit y, to mit igated r isk of cross-contamination, and a more environmentally efficient use of resources," he adds. "The advan- tages of SUS ca n a lso be su m- marized in one word, and that is 'reduction': of upfront capital cost by 50 –75%; of building time of new biomanufacturing facilities by 30 –40%; of water, energy, and carbon footprint by 50 –80%; and ultimately, a reduction in labor by 50%." Ag reeing w it h Ga lliher, R ick Morris, senior v ice-president of R&D at Pall Biotech, notes that some of the benefits of SUS have become well-known, while oth- ers are only starting to be real- ized now that adoption of SUS is g row i ng a nd a s te c h nolog y evolves. "Most notably, SUS helps to decrease facility footprints and offer the flexibility of supporting various applications with quick and easy changeover," he says. "SUS shorten the time to market with the elimination of labor and resource intensive cleaning and validation process required with traditional stainless-steel systems. Par tic ularly as we see facilities b e i ng re f u rbishe d or pu r p ose - b u i l t t o a c c o m m o d a t e m a n y products in one location, these advantages are great over time." By using disposable SUS, not only can biomanufacturers elimi- nate the cleaning and steriliza- t ion steps, a nd t i me i nvolve d w it h t hese steps, but a lso ca n reduce the risk of cross-contami- nation, which is a concern for all in biomanufacturing. "This risk occurs when bioprocessing equip- me nt i s r e - u s e d ," e mph a s i z e s Ga l l i he r. " Trad it iona l s y ste m s sha r e e qu ipme nt a nd pro duc t flow paths, adding to the risk of c r o s s - c o nt a m i n at io n b e t w e e n production batches or different products. Since single-use mate- r ia ls a re d isca rded a nd not re- used after every batch, the risk of cross-contamination in single-use systems is greatly reduced." A nother aspect that deser ves considerat ion for Helene Pora, v i c e - p r e s i d e n t o f Te c h n i c a l C om mu n ic at ion & Reg u lator y Strateg y at Pall Biotech, is that the industr y is becoming more familiar with the environmental benefits of SUS. "This can seem counterintuitive because for the contac t layer, we a re replac ing sta in less w it h plast ic, but it is true. In fact, the biopharmaceuti- cal industry only accounts for less than 1% of plastic usage globally, even as adoption rates continue to rise," she reveals. "Additionally, large amounts of water are being saved by elimi- n at i n g t he ne e d for c le a n i n g and preparation, which resolves wastewater a nd tox ic leac h i ng issues," Pora continues. "It is true that there is a different type of waste created when using SUS, but the industry is quickly com- ing up with solutions to address t his challenge. T he indust r y is also aligning to define standards to guide users in the most effi- cient applications of SUS, create clear expectations for extractables and leachables of source materi- als, and offer sustainable waste management solutions." EVOLUTION OF SUS "Si ngle -use tech nolog ies (SU T ) have rapidly evolved beyond just bio c ont a i ne r s, ste r i le c on ne c- tors, and filter capsules to fully integrated single-use sets," says Mor r is. " T he re ha s b e e n a lot of foc us on si ngle -use sensor s to monitor and process analyti- cal technologies (PAT) to further autom ate t he s e pro c e s s e s a nd decrease operator involvement— this not only increases safety and efficacy across the board, it also streamlines the processes for effi- ciency and quality." In Galliher's opinion, the evo- lution of SUT within the bioman- ufacturing space has seen them b e c o m e w i d e l y a c c e p t e d a n d as such are now much more of a mainstream approach to con- duct eff icient operations. "One of the reasons for this growth is the extensive offer ing that has been continuously developed to accommodate the needs of indus- try, specifically—flexibility, effi- ciency, speed, and lower cost at smaller scale," he says. As the industr y evolves, Pora explains that a key par t of the discussion remains on the topic By using disposable SUS, not only can biomanufacturers eliminate the cleaning and sterilization steps, and time involved with these steps, but also can reduce the risk of cross- contamination, which is a concern for all in biomanufacturing.

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