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BIO INNOVATION NOTES Innovation In Disposable Connectors T By Eric Langer, president and managing partner, BioPlan Associates, Inc. he single-use application market in biopharmaceutical manufacturing is rapidly expanding and highly innovation-driven. Adoption of single-use equipment in early manufacturing has reached a level of maturity that will spill into commercial scale manufacturing in the near term. Indeed, results from our 10th Annual Report and Survey of Biopharmaceutical Manufacturers (www.bioplanassociates.com/10th) indicate that nearly half of biopharmaceutical manufacturers and CMOs either strongly agree (18 percent) or agree (28 percent) that they expect to see 100 percent single-use facility in operation within five years. Those are big expectations — and if they are to be met, some critical hurdles may need to be crossed. One of them is developing standardized applications and connectors. Connectors are needed because they permit interconnectability between various components and between different vendors' devices. This plug-and-play approach ultimately enables further adoption of disposable devices and reduces the risk of being locked into a single component supplier. It's no surprise, then, that disposable bags and connectors top the areas in which the industry is demanding innovation and better products. When we asked respondents where they want their suppliers to focus their new product development efforts, a leading 44 percent pointed to basic devices such as disposable bags and connectors. This response ranked 4 percent above the next mostdesired innovation (disposable probes and sensors, at 40 percent). Other disposable devices also appear near the top of the list, including innovation in disposable bioreactors and disposable purification products. Interest in disposable-bags-and-connectors innovation is higher in established biomanufacturing hubs, with U.S. respondents and Europeans leading the way (47.7 percent and 45.7 percent, respectively). Respondents from the rest of the world have expressed less interest in innovation in this area (26.1 percent) — this year they're more concerned with process development services. This difference is likely due to the fact that early pipeline products in the U.S. and EU, made using single-use devices, are now reaching laterstage production. As such, the need for better products for commercial scale production is now becoming more acute. 20 LifeScienceLeader.com August 2013 INCREASED INTEREST IN CONNECTIVITY OVER TIME The biopharmaceutical manufacturing community's interest in innovative disposable connectors appears to have risen over the past couple of years, perhaps as the industry recognized what a crucial role the devices can play by introducing them into existing single-use product lines (e.g. substrate feeds via novel bags, molded manifolds, and plastic connectors to enable fed-batch, repeated batch, or perfusion modes of bioreactor operation). This year's 44 percent expressing an interest in connectors innovation is a step up from 40 percent last year and 37 percent in 2011. Interest in connectors innovation is increasing alongside adoption of these devices. Among respondents to our study who use disposables, 8 in 10 already say they're using connectors and clamps at some stage of manufacturing. The data in the study shows these devices have become more critical over time, growing from 68.3 percent adoption in 2007 and 47.6 percent in 2006, the early years of single-use product introduction. In fact, the compound annual growth rate in adoption for these products between 2006 and 2013 stands at a healthy 7.5 percent, the fifth-fastest growth rate of the 14 single-use products we identified in our study. LOOKING FORWARD When we evaluated the importance of single-use connectors, we found that nearly all bioprocessing professionals (84 percent) are relying on their suppliers to develop and standardize better connector compatibility (See Fig 2). This demand is likely to push suppliers to consider more "open" designs that do not lock end users into a single format or supplier. Growing adoption of and interest in disposable connectors means that vendors will likely enjoy a healthy demand for their new products. However, these small devices also command only small budgets: When we estimated the average budget per facility on different single-use components, we found that the average respondent budgets just over $25,000 for connectors and clamps. That's far below other more complex single-use applications such as filter cartridges, depth filters, bioreactors, and buffer containers. While that may suggest that vendors may find better margins with other innovative products, it also means that connectors — as smaller lineitems — may find an easier path into the budget. Indeed, effective integration into both process and business systems