Newsletter | January 11, 2012

1.11.12 -- Single-Use Biomanufacturing Devices In High Demand

Bioresearch Online
Single-Use Biomanufacturing Devices In High Demand
By Eric Langer, BioPlan Associates, Inc.

Eric Langer, BioPlan Associates, Inc. Single-use devices are in hot demand as the biopharma industry looks for new, more innovative products. In fact, disposables make up the top 3 of 20 areas of new product development interest this year. According to the BioPlan Associates 8th Annual Report and Survey of Biopharmaceutical Manufacturers, disposable product and purification, was cited by 37.9% of global biopharma respondents. This was up by nearly 10% from last year's study.
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Featured Articles

Increase Production Efficiencies With Single-Use Transfer Lines
Biopharmaceutical manufacturers are implementing new ways to leverage existing plant infrastructure to enhance process reliability and flexibility. One solution that continues to gain momentum is single-use systems — particularly single-use transfer lines — which can deliver significant value through added flexibility, improved asset/equipment utilization, and increased cost savings. Read more.

Executive Insights Into Single-Use: Jerold Martin Of Pall Life Sciences
"Single use, in general, is well accepted by regulators," says Pall's Jerold Martin. "The FDA has stated a preference for single-use, particularly for production of clinical batches, due to elimination of the need for cleaning and cleaning validation, as well as confidence in third-party gamma irradiation and sterilization validation. Preassembled systems and sterile connectors are also perceived as providing reduced risk of microbial contamination of sterile systems compared to traditional aseptic connection assembly, and even systems that are steam-sterilized in place (SIP)." Read more.

Single-Use And Sustainability: No Longer A Contradiction?
When GE's Gerard Gach was asked to develop a single-use product line, he wanted to make sure that the company wasn't going to make anything that would have a negative impact on the environment. Rob Wright recently had the opportunity to sit down with Gach, to get caught up on single-use as a sustainability initiative. Read more.

Thank you for reading Bioresearch Online's Single-Use Insights. Do you have a topic you would like to see addressed in future issues, or do you have experience with single-use technology that you could share? Let us know!

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