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Feb 15, 2011 (Vol. 31, No. 4)

Biomanufacturers Weigh In on Disposables

Many Would Like to See More Product Ideas and Innovations from the Cast of Suppliers

  • Growth, Acceptance, and Restrictions

    Click Image To Enlarge +
    Table 2. Reasons for restricting use of single-use devices, 2011 vs. 2010: The percent of survey respondents indicating “strongly agree” or “agree” is shown.

    Comparing this year’s report data on industry growth to last year’s, we find remarkable stability in the problems the industry continues to face. This may suggest that vendors are doing little to resolve end-users’ top problems. We evaluated 13 areas of concern; the top four product-related reasons are shown in Table 2.

    Growth and acceptance of disposables is clearly tied to the ability to meet end-users’ needs. There is now plenty of data available on these devices, and decision-makers have had enough time to evaluate single-use applications and models for their specific applications. So the engine for growth in this industry segment is more likely to be new product innovation that meets end-user needs.

    Of course, the problem with new technologies in a regulated environment is that they are not quickly accepted by regulators without sufficient data from testing, or prior use. Thus, there is a built-in bias toward incremental improvements that don’t involve drug product contact. New, wider ranges of materials from which to manufacture single-use devices, and a better understanding of these materials will help ensure long-term growth in this industry segment. But this will require stamina and resources on the part of industry vendors.

Readers' Comments

Posted 03/09/2011 by Cathy Edgington

with extractables and leachables being number one concern, where do the fluoropolymers fit into the equation?

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