Disposables seek validation aids

Single-use technologies provide automation suppliers the opportunity to develop and offer validation-ready templates or protocols and modular equipment control strategies that simplify validation. In addition to minimizing facility set-up time and cost, such offerings might also help the fledgling single-use market develop.

Disposable technology has enjoyed "rapid adoption" over the past five years, according to Janice Abel and John Blanchard of ARC Advisory Services. They have penned a report, Disposables Help Drive Operational Excellence in Pharmaceutical and Biotech Manufacturing, which finds most of the adoption occurring for clinical and smaller scale production. Future applications, they say, will also include production of vaccines and personalized medicines. 

The combination of automated validation aids and single-use processing could help move vaccine manufacturing closer to the populations in developing countries that often can't access them. Modular single-use systems, which often contain built-in contamination control measures, offer a kind of quick-set-up facility that removes some of the infrastructure barriers to the construction of production plants in the developing world. And closer to home, Congress listened to a pitch last summer, as we reported, to create a public/private partnership for medical countermeasures vaccine manufacturing based on the technology

The ARC report is available to clients, and to non-clients for a fee.

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