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|Articles|October 20, 2014
Wuxi's Biologics Facility Receives Honorable Mention at ISPE Facility of the Year Awards 2014
Author(s)BioPharm International Editors
The WuXi AppTec bulk cell culture production facility, designed by Sartorius Stedim Biotech (SSB), received an honorable mention in the 2014 Facility of the Year Awards at the annual meeting of International Society for Pharmaceutical Engineering (ISPE) in Las Vegas last week.
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The WuXi AppTec bulk cell culture production facility, designed by Sartorius Stedim Biotech (SSB), received an honorable mention in the 2014 Facility of the Year Awards at the annual meeting of International Society for Pharmaceutical Engineering (ISPE) in Las Vegas last week.
WuXi AppTec had to design and build a flexible, cost-effective, multiproduct facility for biologics production in line with cGMP standards for the US, EU, and China within a short timeline.
SSB’s bioprocess design consultant team performed the risk assessments to evaluate the relative impact of traditional versus single-use technologies. It was estimated that WuXi would be able to considerably reduce its timeline by selecting a fully single-use process train, thus decoupling the process design from the facility build. The team carried out process modeling to evaluate equipment sizing and identified opportunities for downsizing utilities and for meeting higher classification room requirements by working with single-use technology.
SSB’s expertise in the design and implementation of fully single-use process trains enabled WuXi to achieve its goal in 18 months and become the first biologics production facility in China to be compliant with cGMP standards for the US, EU, and China.
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