AUBAGNE, France & GOETTINGEN, Germany & ST. PAUL, Minn.–Sartorius Stedim Biotech (Paris:DIM) has entered into an agreement with WuXi AppTec, Inc., a wholly owned operating subsidiary of WuXi PharmaTech (NYSE:WX), to cooperate on viral clearance studies. Under this agreement, WuXi AppTec will provide the relevant viruses, materials and methodologies to Sartorius Stedim Biotech to employ in conducting non GLP viral clearance testing of its technologies with customer products and for supporting its own research and development activities.
Sartorius Stedim Biotech markets an orthogonal and fully integrated three-step viral clearance technology platform to the biopharmaceutical industry. To further support its customers and to meet anticipated regulatory expectations, Sartorius has built an in-house laboratory for non-GLP viral clearance testing of its technologies.
The cooperation with WuXi AppTec will benefit customers because non-GLP viral clearance testing during early-stage process development will allow Sartorius to recommend the best Viral Clearance Technology option. Sartorius and WuXi AppTec will be using the same viruses, materials and methodologies so that customers can reliably anticipate – at this very early stage – predictive study results of what might be expected from WuXi AppTec´s GLP Viral Clearance testing of the same product as part of the IND process and ultimately the Phase 3 validation process.
Viral clearance studies performed during the early stage of process development often help process decisions and provide information about the viral inactivation or removal mechanism. Major regulatory bodies around the world require that companies demonstrate that their purification process has the ability to clear viruses before the drug product receives marketing authorization.
“Viral clearance studies are gaining more importance at early stage process development and with WuXi AppTec we have found an excellent partner to realize both early stage non-GLP testing at Sartorius and GLP testing at WuXi AppTec,” stated Reinhard Vogt, Vice CEO Sales and Marketing and Member of the Board of Sartorius Stedim Biotech.
“We are very pleased to be able to partner with Sartorius Stedim Biotech in offering this unique benefit for biopharmaceutical manufacturers,” said WuXi AppTec Vice President Larry Thomas. “It is a perfect fit with our company’s commitment to providing clients with seamless single-source solutions to help shorten the time from initial process development to a successful IND.”
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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, filtration, purification, fluid management and lab technologies are supporting the biopharmaceutical industry around the world to develop and produce drugs safely, timely and economically. For next generation processes, 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” on a daily basis. 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 over 2,300 people, and in 2007 generated pro forma sales revenue of 375.9 million euros.
A profile of WuXi PharmaTech
WuXi PharmaTech is a leading pharmaceutical, biotechnology and medical device R&D outsourcing company, with operations in China and the United States. As a research-driven and customer-focused company, WuXi PharmaTech provides pharmaceutical, biotechnology and medical device companies a broad and integrated portfolio of laboratory and manufacturing services throughout the drug and medical device R&D process. WuXi PharmaTech’s services are designed to assist its global partners in shortening the cycle and lowering the cost of drug and medical device R&D. For more information, please visit: www.wuxipharmatech.com.
WuXi AppTec is a wholly owned operating subsidiary of WuXi PharmaTech and it has three FDA-registered U.S. facilities located in Philadelphia, PA; St. Paul, MN; and Atlanta, GA.