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Bioprocessing CMOs Continued from page 40 For example, Fujifilm Diosynth Biotech- nologies is expanding its mammalian cell culture offerings using single-use bioreactors. "To meet market and customer demand we have significantly expanded our mamma- lian cell culture offering at both our U.S. and U.K. sites," said Steve Bagshaw, managing director for the company. "Early this year at our Research Triangle Park site we brought on-line a single-use 1,000 L bioreactor that enables us to offer flexibility of operations to better serve the demands of companies requir- ing material for pre-clinical studies, early- to mid-phase clinical production, and beyond." Fujifilm Diosynth Biotechnologies is also building a cGMP mammalian cell culture fa- cility at its Billingham, U.K., location, which will replicate its RTP mammalian cell cul- ture operations. In addition to implementing single-use bioreactor capacity, many CMOs are also implementing disposable technologies in downstream purification. The need for downstream improvements results in part from the work that led to higher cell culture titers over the past decade. In many instances, higher titers caused the biomanufacturing production bottleneck to shift to downstream purification, thereby reducing the overall benefits available from Sandoz recently scaled up the PEGylation of proteins to the 13,000 L scale. 13% 9% 7% 3% 2005 2007 2009 2011 Planned annual capacity growth over last seven years implementing higher titer processes. For example, Boehringer Ingelheim and WuXi App Tec (www.wuxiapptec.com) have imple- mented disposable technologies in both their upstream and downstream processes. "Boehringer Ingelheim is adding fully disposable processes to our stainless steel capacity, which includes all upstream and downstream process steps," said Julia Kneb- el, director marketing and communications, contract manufacturing business, biopharma- ceuticals at Boehringer Ingelheim. "A fully disposable process is one of the technology areas that has been fully evaluated and is no longer a future technology but more a present reality. Alternative technologies to chromatography are also very much in focus. Recent advances in membrane technologies such as membrane absorbers are having an impact throughout the purification process." "In the near term, membranes will im- prove the efficiency and effectiveness of pro- cess-based impurity removal such as virus and DNA removal, but in the future, may also impact specific product based impurity removal." WuXi AppTec recently completed con- struction of a new GMP manufacturing facility that employs disposable systems, in- cluding 1,000 L bioreactors. "The entire operation employs disposable systems, both upstream and downstream, which greatly facilitates product changeovers, while reducing operational costs," said David Fischer, business development manager, pro- tein therapeutics at WuXi AppTec. "We also will be expanding our dispos- able bioreactor capacity to 2,000 L by the end of the second quarter in 2013." William Downey (wdowney@ hightechdecisions.com) is president and Dawn Miles is senior market analyst of HighTech Business Decisions (www.hightechdecisions.com). 42 | October 1, 2012 | genengnews.com | Genetic Engineering & Biotechnology News HighTech Business Decisions