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JULY 2014 19 LIFESCIENCELEADER.COM Survey Methodology: The 2014 Eleventh Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Pro- duction yields a composite view and trend analysis from 238 responsible individuals at biopharmaceutical manufacturers and contract manufacturing organizations (CMOs) in 31 countries. The methodology also included over 173 direct suppliers of ma- terials, services, and equipment to this industry. This year's study covers such issues as: new product needs, facility budget changes, current capacity, future capacity constraints, expansions, use of disposables, trends and budgets in disposables, trends in downstream purifi cation, quality management and control, hiring issues, and employment. The quantitative trend analysis provides details and comparisons of production by biotherapeutic developers and CMOs. It also evaluates trends over time and assesses differences in the world's major markets in the U.S. and Europe. For Your Clinical-Scale & Larger Bioprocessing, Which Type Of Single-Use Connectors Do You Prefer? Reasons For Selecting Connectivity Gender for their preference for gendered rather than genderless connectors. This sug- gests some ambiguity: While the industry wants genderless connectors, its most common reason for selecting a connec- tor focuses around risk mitigation (over a third lean toward risk factors, vs ~71 percent focusing on reasons related to genderless connectivity). Representative comments offered along with the survey responses are similarly illuminative: In favor of gendered connectors: "Risk mitigation with regard to incorrect connections — possibility to establish workflows based on 'one-way- correct' connection [connectivity defines the process]." "Gender-sterile connectors [ends are different] are more reliable in my opinion." "Lower risk of incorrect use." "The biggest contributor to [problems] in single-use production is the operator. This is a small and easy way to minimize errors." In favor of genderless connectors: "Genderless help with inventory control and simplify preparation." "Allows the flexibility to choose which attachment to make at any given point in the process." "You always want it to be as simple as possible." "Having genderless connectors allows for more flexibility when having to come up with disposable strategies." "Easier to set up bags and tubing with connectors that can connect to each other for multiple combinations." VENDORS SHOULDN'T REST EASY While study participants seem to prefer genderless sterile connectors, questions of reliability are paramount, and as one respondent noted, there are other ques- tions surrounding cost and availability to consider. That suggests the choice may not be as clear-cut as it initially might appear. One thing seems clear from BioPlan surveys: The industry is looking for inno- vation in this area. According to our latest industrywide study, some 38 percent of respondents consider disposable bags and connectors to be among the top five areas they want their suppliers to focus their development efforts on. That was the fourth-highest result of the 21 innova- tion areas listed in the study. These devic- es have consistently seen hot demand for innovation over the past eight years. Suppliers responding to the study were a little less committed to innovation in this area, though. Asked which new technolo- gies or new product development areas they are working on today, roughly one-quarter (27.3 percent) cited disposable connection technology. As vendors look to increase their market penetration, standardization of their products — including of connectors — may be unavoidable. Currently, while three-quarters of the industry believes it important or very important that single- use vendors standardize their devices, only 28 percent are satisfied to any degree with their current vendors in terms of device standardization. As one director of technology for a large biopharma noted, "Suppliers will only truly achieve the SUS (single-use system) value proposition they champion if they resolve these variability concerns." For manufacturers of single-use connectors, end user desire for standardization is par- ticularly acute. Some financial pain may be inevitable in the short term, but suppli- ers may well win in the long term by stan- dardizing their offerings to meet end user demand. An interesting bellwether for the industry's commitment to standardiza- tion may be in the most basic of choices: gendered — or genderless. L Figure1 Figure2 Source: BioPlan Associates Single-Use Connector Study, April 2014 Source: BioPlan Associates Single-Use Connector Study, April 2014 ■ Genderless-Sterile Connectors (both ends are the same) ■ Gender-Sterile Connectors (ends are different) 34.6% 23.1% 23.1% 15.4% 3.8% 73.1 26.9 Risk Mitigation Flexibility Simplicity Inventory Control Reliability 0 7 1 4 _ B i o I n n o v a t i o n . i n d d 2 0714_BioInnovation.indd 2 6 / 2 3 / 2 0 1 4 2 : 5 4 : 5 0 P M 6/23/2014 2:54:50 PM