SSB’s Production Facility Design for WuXi AppTec Receives Honorable Mention at the ISPE Facility of the Year Awards 2014

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. The awards were presented by the International Society for Pharmaceutical Engineering (ISPE) at its Annual Meeting in Las Vegas last week.

WuXi AppTec faced the challenge of designing and building a highly flexible, cost-effective, multi-product facility for biologics production in line with cGMP standards for the US, EU and China within a short timeline. The company involved SSB’s bioprocess design consultant team early on in its planning stage. The SSB team performed risk assessments evaluating the relative impact of traditional versus single-use technologies. SSB estimated that WuXi could 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.

Benefiting from SSB’s expertise in the design and implementation of fully single-use process trains, WuXi was able to achieve its goal in 18 months from conceptual design to commissioning and startup, and became the first biologics production facility in China to be compliant with cGMP standards for the US, EU, and China.

“SSB’s performance surpassed our expectations,” said Dr Ge Li, Chairman and CEO of WuXi AppTec. “We were delighted with the efficiency of SSB’s project management and with their expertise in single-use process implementation. We now have a highly flexible facility with scalable, disposable equipment from 50 L to 2,000 L, designed to meet the rapidly changing requirements of our clients. We are proud to be the manufacturer of the first biologics produced in China for clinical trials in the US.”