Reducing Cycle Time
Other speakers at the summit pushed home the point that decreasing cycle times can also aid profitability. Friedrich Nachtmann, Ph.D., head of biotech cooperations at Sandoz (www.sandoz.com), presented data to show that by beginning the next primary protein isolation at the same time as the protein purification run, Sandoz could produce three batches of protein in 15 days instead of two.
"By making small investments and organizational changes in the plant we have reduced our cycle time from seven days to four and significantly reduced our manufacturing costs," Dr. Nachtmann says.
Martin Wrankmore, continuous improvement lead at Lonza Biologics (www. lonza.com), proposed an alternative method of cutting down cycle time. Wrankmore presented a number of applications where the use of disposable technology is saving Lonza time with cleaning and cleaning validation, plus increasing process robustness.
For example, Lonza uses plastic tank liners and bioprocess containers to replace precleaned stainless steel tanks. The tank liners are used for cell culture medium and feed preparations and the bioprocess containers for medium, feeds, buffers, and sample collection.
In addition, there is also an increasing use of tube welding and disposable bioreactors. The tube welding is used to connect disposable to stainless steel reactors, and according to Wrankmore, using it saves more than two hours of traditional cleaning time.
The bioreactors replace two sets of inoculum fermenters, and although they have a 50-L capacity, are used like a large shake flask. To complete the upstream process, Lonza is also using disposable harvest systems for harvesting 200 L of fed batch fermentation.
"Using disposable technology in much of our upstream process is saving days of on-site preparation work so that we can decrease turn-around times, reduce the potential risk of product cross-contamination, and focus on product delivery," says Wrankmore.
"The ongoing challenges we now face are an increasing reliance on our suppliers for delivery and flexibility in their design approach. We also have to carefully balance out the cost of the plasticware against the time and resources it would have taken to clean our process plant. However, due to the proven benefits of disposables to date, we are evaluating their use in our downstream purification processes."