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- Title
Standards-Setting for Single-Use Equipment in Biopharmaceutical Manufacturing: An Update on Progress; and the Impact of Standards Implementation.
- Authors
LANGER, ERICS.
- Abstract
The development of standards for single-use devices in bioprocessing is critical to the advancement of these novel devices. Over the past five years, developers, inventors, and producers have increased their dialog and have recognized the need for a balance between the end-users' demand for greater uniformity and the suppliers' need to protect and foster innovative technology and better designs. Documents and recommendations are being developed by numerous organizations to provide this balance. However, many areas of standards development remain challenging. Single-use designs are proprietary and developers need to protect their intellectual property. Yet end-users will not accept becoming locked into a single supplier even if a particular vendor has the best design and product. Thus, the industry continues to wrestle with building a consensus between the end-users' need for consistency and the suppliers' need to avoid stifling innovation. As SUS standards are implemented, there is general agreement that they will positively affect both end-user decision-making and will likely increase adoption of innovative devices. Standards will shorten development time for novel materials and designs and will shorten the time for end-users to qualify new suppliers -- leading to more and better (healthy) competition. Standards will allow more effective product comparisons, reduce repetitive inventions by competitors, and simplify GMP implementation of single-use technologies. SUS standards will benefit the industry as a whole by establishing uniform quality and performance which will help enable better process monitoring, reduce validation costs, and shorten end-user implementation timelines. This will increase growth rates for the SUS industry and ultimately permit more cost-effective biologies manufacturing by more drug innovators at more facilities around the globe.
- Publication
BioProcessing Journal, 2012, Vol 11, Issue 3, p20
- ISSN
1538-8786
- Publication type
Academic Journal
- DOI
10.12665/J113.Langer