"Biopharmaceutical manufacturers have been using HFC39 connections for years, proving the product's reliability," says John Boehm, business unit manager, bioprocessing. "Now we have validated its aseptic disconnect capability, giving bioprocessors the confidence to use the HFC39 in their most critical applications."
Figure 3. Pre-assembled hardware:
Meanwhile, Pall Life Sciences, East Hills, N.Y., unveiled a flexible single-use depth-filter capsule system for demanding pre-filtration and clarification processes (Figure 4). The Stax system integrates as a pre-filtration step — for example after a disposable bioreactor — and makes it easier to develop a complete single-use process.
"The Stax high-performance depth filter system has engendered a considerable amount of interest because of the flexibility of the system. Because capsules are available in three different surface-area configurations, which can be mixed and matched to give exactly the capacity required for any given process or batch size, and because the capsules can be used within a holder — which we call a 'chassis' — in standard bottom-in/bottom-out or bottom-in/top-out configurations, as well as having the useful function of being able to be operated with two different grades of capsules within a single chassis, users who have already installed the system are very enthusiastic," explained Ian Sellick, director of marketing.
Figure 4. Flexible filter: The design of this
On a broader scale, the notion of a "process-in-a-box" (http://www.ChemicalProcessing.com/articles/2007/185.html) is now a reality, according to Sellick. "It is now perfectly feasible to have a complete process delivered as a disposable system, within certain capacity constraints. A process requiring up to 1,500-or-so-liter capacity at any given hold stage can be readily provided. If greater capacity is required, large biocontainers can be manifolded together and interconnected using simple, reliable sterile connectors."
From a practical point of view, such a system comes as a series of pre-sterilized sub-assemblies. Each is joined together — usually when that part of the process is reached — using sterile tube connectors. "Once a part of the process is finished, the tubing is sealed and cut maintaining the sterility of the system or a sterile disconnect device is used," he adds.
A significant benefit of the single-use approach is that identical systems can be used at early clinical stages as well as for large-scale manufacturing with no change in materials of construction, says Sellick. "Scale-up by multiplexing is the perfect solution to planning larger-scale manufacturing without having to risk capital at an early stage of the product lifecycle."
Different Economy, Different Challenges
Disposables actually may benefit from today's downturn. Weakness of the overall global economy coupled with growing scrutiny of healthcare costs in the U.S. and elsewhere will impact bioprocessing, explains Sellick. It inevitably will prompt increased attention to the costs of manufacturing and delivering pharmaceutical products to patients — and so provide a potent driver to reevaluate process economics. "This in turn should lead to the development and adoption of new technologies that will be to the long-term benefit of everyone. Process economics will really be the watchword," he concludes.
Seán Ottewell is Chemical Processing's Editor at Large. You can e-mail him at firstname.lastname@example.org.