The WuXi AppTec bulk cell culture production facility designed by Sartorius Stedim Biotech (SSB), a leading international supplier of pharmaceutical and biotech equipment, 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 U.S., 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 U.S., EU, and China.
“Sartorius Stedim Biotech’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 United States.”
Sartorius Stedim Biotech offers the most comprehensive, fully scalable range of products from laboratory to plant, supported by a full bioprocess design consultant service. The compelling range of SSB’s technologies and services enables biomanufacturing companies to develop and manufacture drugs using fast, safe and cost-effective bioprocesses.
A profile of Sartorius Stedim Biotech
Sartorius Stedim Biotech is a leading provider of cutting-edge equipment and services for the development, quality assurance and production processes of the biopharmaceutical industry. Its integrated solutions covering fermentation, cell cultivation, filtration, purification, fluid management and lab technologies are supporting the biopharmaceutical industry around the world to develop and produce drugs safely, timely and economically. Sartorius Stedim Biotech focuses on single-use technologies and value-added services to meet the rapidly changing technology requirements of the industry it serves. Strongly rooted in the scientific community and closely allied with customers and technology partners, the company is dedicated to its philosophy of “turning science into solutions.”
Headquartered in Aubagne, France, Sartorius Stedim Biotech is listed on the Eurolist of Euronext Paris. With its own manufacturing and R&D sites in Europe, North America and Asia and a global network of sales companies, Sartorius Stedim Biotech enjoys a worldwide presence. Its key manufacturing and R&D site is in Germany. The company employs approx. 3,300 people, and in 2013 earned sales revenue of 588.4 million euros.