Life Science Leader Magazine

AUG 2013

The vision of Life Science Leader is to be an essential business tool for life science executives. Our content is designed to not only inform readers of best practices, but motivate them to implement those best practices in their own businesses.

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BIO INNOVATION NOTES defines successful applications of single-use systems versus unsuccessful ones, and so far at least, most of the focus has been on physical connections such as tubing and connectors, giving them a leg up on other products. Given healthy penetration of disposable connectors — and growing end user desire for innovation — it's likely that the industry will continue to see a number of innovations in this area. Vendors will need to consider standardizing these devices to satisfy end user demand. With disposable devices continuing to make inroads into commercial biomanufacturing, we can expect that the importance of connectors and clamps will only rise over time. These devices enable the shift towards disposable usage, and innovation should continue as vendors recognize that their use (and standardization) is crucial in the continued maturation of the disposables market. Figure 1: Selected New Product Development Areas Of Interest U.S. vs. Western Europe vs. Rest Of The World 47.7% 45.7% Disposable Products: bags, connectors, etc. 26.1% Disposable Products: probes, sensors, etc. Disposable Products: bioreactors U.S. Only 31.4% 21.7% Western Europe Only Rest Of The World 46.5% 31.4% 26.1% 38.4% 34.9% Disposable Products: purification 17.4% 42.9% Figure 2: Single Use/Disposables Standardization Factors "In my opinion, single use/disposables vendors need to work harder to standardize." Very Important Important Connector Compatability 47.8% 36.7% *The remaining 15.5% indicated "unimportant or don't know." Survey Methodology: The 2013 10th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production is an evaluation by BioPlan Associates, Inc. that yields a composite view of and trend analysis from 300 to 400 responsible individuals at biopharmaceutical manufacturers and CMOs in 29 countries. The respondents also include more than 185 direct suppliers of materials, services, and equipment to this industry. Each year the study covers issues including new product needs, facility budget changes, current capacity, future capacity constraints, expansions, use of disposables, trends and budgets in disposables, trends in downstream purification, quality management and control, hiring, 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. If you want to learn more about the report, please go to bioplanassociates.com. 22 LifeScienceLeader.com August 2013

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