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www.biopharminternational.com June 2019 BioPharm International eBook 7 Single-Use Systems Manufacturing of standardization of mater ials and processes. "SUT decrease the foot pr int, resou rces, a nd labor required to manufacture dr ugs. They also increase safet y, from an operator and end user perspec- tive, and are gentler on our envi- ronment," she adds. "However, as we ma ke foot pr ints sma ller, and integrate processes f urther, we must be able to ensure that innovation is effective and sup- ports fully the validation of the drug manufacturing process doc- umented, which is why standard- ization is so critical." C u r r e n t l y, b i o m a n u f a c t u r- ers have the capabilit y to oper- ate whole processes using SU T, states Chatel, but t he major it y of companies utilize a combina- tion approach as a result of eco- nom ica l a nd prac t ica l reasons. He highlights the fact that cell culture and bioreactors are com- mon areas where SUT are widely available, yet there are physical constraints of these areas, such as limitations on the batch scale to about 2000-L. "A n a r e a w h e r e S U T h a v e yet to ga i n f u l l accept a nce i s c h r o m a t o g r a p h y, e s p e c i a l l y where expensive resins prov ide the best product capture options, which means that re-utilization in acrylic columns is in fact still more economical than available SUT," Chatel says. "In the future, my v ision is t hat mater ia l sc i- ence will play an ever-increasing role in the evolution of SU T to develop novel, d isposable, a nd environmentally friendly materi- als w ith physical and chemical properties that address the needs for purity, safety, and quality of the biopharmaceutical industry." For Galliher, the near future is not based upon predictions, but on developments that are already underway and presently starting to redef ine biotech. "Adva nces in higher performance systems, m o r e a d v a n c e d a u t o m a t i o n , a nd r e - u s a ble s i n g le - u s e c o n - nectors are underway," he adds. " Mo no c lo n a l a nt i b o d y (m A b) titers of 100 g/L are within reach in the next few years. Solutions based on a combination of data acquisition, advanced analytics, and cloud ser v ices enables bio - manufacturers to understand the predictabilit y of manufacturing events a nd opt im i ze asset per- for mance, which means that it is possible to safeguard the best quality and standards. One such example is the Predix platform (GE Healthcare), which provides de e p i n sig ht s i nto t he m a nu - fac t u r i ng process by mea ns of a d v a nc e d d at a a n a l y s i s a l go - rithms." IMPROVING MANUFACTURING FLEXIBILITY In addition to reducing the batch time and the validation burden of traditional stainless-steel facili- ties, SUS can also increase manu- facturing flexibility, states Chatel. "I n compa r ison to t rad it iona l fac ilit ies w it h la rge equ ipment c on ne c te d w it h c omple x a nd fixed piping net works, SUS can be read i ly adapted a nd moved to address changing production needs—whether being a capacity increase or the production of a new molecule," he notes. Although there is an increase i n out lay m ate r ia l cost s, a s a result of the need to recurrently purchase consumable items, the decrease that is experienced in t he o p e r at io n a nd v a l id at io n whe n u s i n g S U S i n c om b i n a - tion with the increased flexibil- ity afforded by the systems give ove r a l l favor able pro c e s s e co - nomics, Chatel emphasizes. "The flexibility that SUS provide also enables a dramatic reduction and sh i f t i n t he t i me re qu i re d for capital investment before reach- ing full production capacity," he says. "T h rough t h is d i f ference in required capital investment, smaller businesses and emerging economies are able to produce the work required to prove the pro- jected successes of their product and as a result to acquire further capital for commercialization." C h ate l a l s o r a i s e s conce r n s, however, that for some countries t hat may b e e me rg i ng w it h i n the biomanufacturing space, the la r ge r a mou nt of w a ste cou ld prove problematic as there is not the infrastructure in place to deal with such waste appropriately. "At Pa l l, we see t he g reatest ability to take advantage of SUS is actually in the case of a facility rebuild, new build, or modular formats," states Morris. "In the case of a refurbishment, existing traditional methods and SUT can be integrated to optimize the life of the investment. With a new build, we are almost at a place in the industry where a fully single- use facility can be implemented with everything connected. And that lends itself to the plethora of modular bioprocessing solu- t ion s h it t i ng t he ma rket w it h everything from quick installa- tion approaches to fully flexible pods that are shipped as ready to use facilities." I t i s i m p o r t a nt t o r e m e m - ber that SUS are still fairly new f o r t h e m a r ke t , a s s e r t s P o r a . "T herefore, across the industr y there is still a mix and match of batc h a nd p er f usion processes using a hybrid of traditional and s i n g l e - u s e t e c h n o lo g i e s ," s h e adds. "A s we see g reater i nter- est in intensified processing for quick implementation in remote locations or to meet unexpected