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8 BioPharm International eBook June 2019 Single-Use Systems Manufacturing demand (emerging nations, epi- demic response, etc.), however, it becomes clear how important SU T a r e to t he f ut u r e of t h i s industry." SOME LIMITATIONS It is generally accepted that sin- gle-use bioreactors are limited to 2 0 0 0 -L , wh ich is a f rac t ion of the capacity of a traditional bio- reactor that can be in the range of 15,000-L or more. "The capac- ity limitation is less of an issue nowadays," says Pora, "due to the cont i nuously i nc reasi ng t iter s. T h e r e a r e l i m i t a t i o n s d o w n - s t r e a m w it h c h r o m ato g r aphy, however. Right now, the largest SU c h romatog raphy colu m n is 60 cm in diameter." Both Morris and Galliher con- cur with Pora about the limita- t ion of t he bioreac tor capac it y a nd t h at t h i s i s not r e a l ly a n issue, presently. "Two thousand l ite r s i s ab out a s muc h c apac- it y a s o p e r ato r s ne e d ," s t ate s Mor r is. "Even i n t he case of a d r u g g o i n g b l o c k b u s t e r, S U S o f f e r s t h e u n i q u e a b i l i t y t o s e a m l e s s l y a n d r a p i d l y s c a l e with parallel processing." "Indeed, st ud ies have show n that single-use is economically and prac t ically favorable when c o m p a r e d w i t h t r a d i t i o n a l st a i n le s s ste e l, of fe r i ng up to 2000 –3000 kg per year at today's titers of 5–10 g/L for mAbs," says Galliher. "However, titers up to 50 g/L have been reported in the industry (2), so this is a dynamic landscape such that capacity limi- tations and cost reductions could advance in the near future." T he r e a r e s o me l i m it at io n s t hat must be considered, how- ever, Galliher states, which are that SUS do not withstand tem- peratures above 60 °C, pressures above one pound per square inch, and non-polar solvents. "A cru- cial aspect when considering the i mplementat ion of SUS is t hat t he supply c ha i n ma nagement r e qu i r e s a c los e col lab or at ion bet ween t he c ustomer a nd t he supplier," he says. "Sec ur it y of supply chain is paramount, and it requires a great management on both sides." ADOPTION IS ACCELERATING As industr y moves toward con- t i nu o u s ( p e r f u s io n) p r o c e s s e s a nd a s biolog ic s a nd biosi m i- lars are increasingly being devel- op e d, it i s e x p e c te d t hat SUS , wh ic h a re wel l-su ited to t hese trends, w ill also be more read- ily adopted. "Particularly in the case of new sta r t-ups, cont rac t deve lopme nt a nd ma nu fac t u r- ing organizations, and contract research organizations, it makes the most sense to work with SUS to ta ke adva ntage of t he f lex i- bility it offers and to be able to work toward continuous opera- tions," says Pora. "A d d it i o n a l l y, a s S U T g a i n f urther acceptance and become more integrated, automation and inline PAT will enable the next ge ne rat ion of me d ic i ne," add s Mor r i s. G oi ng f u r t he r, Mor r i s st ates t hat a s t he re is a lso a n industry trend toward more and more personalized therapeutics, as wel l as t he requ i rement for more f lexible process locations, there could be the potential for a mobile facilit y in the f ut ure. "The potential is great, and this is a very exciting time to be in the industry," he notes. Galliher predicts a big increase in both productivity and capac- ity for SUT, along with a demand boom for smaller-scale SUS and facilities. "Fully- closed systems w i l l enable mu lt i-produc t bio - manufacturing in very efficient op e n b a l l r o om f ac i l it ie s , a nd highly-automated and integrated upstream and dow nstream sys- te m s w i l l op e r ate i n cont i nu - ous mode where it makes sense. M o d u l a r p l u g - a n d - p l a y, s i n - gle-use facilities will gain more interest by offering more speed t o i n s t a l l i n g m a n u f a c t u r i n g capacity," he says. "The biopharmaceutical indus- try is one where time is money, yet sa fet y is necessa r y, so it is c r it ica l to sc reen a nd va l id ate mole c u le s qu ic k ly. S U S of fe r s many solutions to help address t h e s e g o a l s a n d b e n e f i t s f o r users," summarizes Morris. REFERENCES 1. Allied Market Research, " Biopharmaceuticals Market ,", Market Research Report, July 2018. 2. WuXi Biologics, " WuXi Biologics Achieves Breakthrough Titer of 51 g/L in Cell Culture Productivity ," Press Release, Dec. 12, 2018. BP As industry moves toward continuous (perfusion) processes and as biologics and biosimilars are increasingly being developed, it is expected that SUS, which are well-suited to these trends, will also be more readily adopted.

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