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BIO INNOVATION NOTES Snapshot analyses of selected companies developing new life sciences products and... REPORT 18 JULY 2014 LIFESCIENCELEADER.COM BIO INNOVATION NOTES REPORT E R I C L A N G E R President and Managing Partner BioPlan Associates, Inc. BEST PRACTICES IN STANDARDIZING SINGLE-USE DEVICE CONNECTIVITY By E. Langer where both connector ends are the same (hence genderless). These tend to be uncomplicated and require fewer parts for inventory. Gendered sterile con- nectors, with their different ends, are slightly less straightforward to use and require more inventory, but generally are perceived to present a lower risk of incorrect connection. Competitive aseptic options on the mar- ket include GE's ReadyMate (genderless) and Pall's KleenPak (gendered). Each can be gamma sterilized or autoclaved and come in a variety of sizes. Pall was one of the earliest entrants into the field and provided a huge boost when it shortened the connection time by introducing its half-inch connector. INDUSTRY ATTITUDES ABOUT GENDER To gauge industry attitudes to gendered and genderless connectors, BioPlan Associates carried out a small survey of qualified individuals with interesting results. Some 73 percent of the 26 respon- dents surveyed said they prefer gender- less sterile connectors for their clinical- scale and larger bioprocessing, as opposed to the remaining 27 percent who favor gendered sterile connectors. We explored the reasons why respon- dents made those choices. Sorting respon- dent comments into broad categories, the survey yielded some intriguing results: While the simplicity and inventory con- trol afforded by genderless connectors are key considerations, risk mitigation is top of mind with the majority of those who selected risk mitigation as a reason Best Practices In Standardizing Single-Use Device Connectivity he spread of single-use devices in the biopharmaceutical manufacturing industry has been well-documented, with some devices reaching penetration rates approaching 90 percent, according to various studies conducted by BioPlan Associates. Yet there remains plenty of room for further adoption of single-use, disposable devices, particularly in com- mercial scale production, where they have yet to displace traditional stainless- steel systems. But the debates over standardization continue. And even the most basic con- nectors create controversy. The ability to hook up and integrate various devices is an increasingly important factor as single-use applications push into main- stream biopharmaceutical manufactur- ing. Connectors can allow for intercon- nectability between various single-use components and vendor devices, allowing end users a plug and play approach that permits a greater assortment of options. From this perspective, connectors play a significant role in the expanding use of single-use equipment. This industry segment is still in its early stages, and it is currently faced with an assortment of vendor devices, many of which present difficulties with interop- erability. If connectors are to expand single-use penetration, suppliers and end users will likely need to agree on aspects of physical standardization — similar to how computer connectivity moved from various sizes and configurations to more common USB-type connectors. In fact, connector compatibility is one of the most sought after areas for standardization in the single-use arena. In BioPlan Associates' latest annual industry study, the 11th Annual Report and Survey of Biopharmaceutical Manu- facturers (see www.bioplanassociates.com /11th), respondents were asked which of several areas they felt were important for single-use/disposable vendors to work harder to standardize. Connector compat- ibility (interchangeability) was near the top of the list with 88 percent of global respondents considering standardization "important" or "very important." A BASIC CHOICE: GENDER OR GENDERLESS CONNECTORS? The inherent issue with standardiza- tion is that some vendors will have to change their existing product lines to meet whatever standards are set. For con- nectors, the most basic standardization boils down to a binary choice: gender or genderless connectors. Genderless sterile connectors are those If you want to learn more about the report, please go to bioplanassociates.com Even the way devices are connected raises debate 0 7 1 4 _ B i o I n n o v a t i o n . i n d d 1 0714_BioInnovation.indd 1 6 / 2 0 / 2 0 1 4 1 0 : 1 6 : 2 3 A M 6/20/2014 10:16:23 AM