WuXi AppTec is opening a new lab in Germany that will bring out best in class extractables/leachables testing to Europe. The state-of-the-art facility will be located in the Bavarian capital of Munich and will expand our ability to meet the demands of the medical device industry in Europe and beyond with our cutting-edge technology, expertise, and experience.
WuXi AppTec’s new lab in Munich
The new lab is strategically located in Germany’s bustling life sciences ecosystem. Its central Munich location provides convenient access to Germany, Austria, Switzerland, and further afield and is the perfect position for WuXi AppTec’s Laboratory Testing Division.
The lab includes 1,500m2 of dedicated E/L space and has the latest equipment to identify and quantify compounds found in medical device materials. It will serve customers who require specialized services like E/L testing, helping to ensure their products meet the highest possible safety standards and comply with worldwide regulations.
To celebrate the opening of the new testing facility, WuXi AppTec will host an open house on October 23 and a free seminar on October 24 this year. The event will give attendees the chance to meet the experts working at the facility, enjoy an exclusive tour of the new lab, and participate in networking opportunities. The team will also host a free training session on ISO 10993, the set of standards used to evaluate the biocompatibility of medical devices to manage biological risk. Click here to RSVP.
Two of WuXi AppTec’s experts in extractables/leachables testing and toxicological risk assessment will lead the seminar: Sandi Schaible, Executive Director of Analytical Chemistry and Regulatory Toxicology, and Dr. Kimberly Ehman, Ph.D. DABT, Director of Regulatory Toxicology.
Meeting demand for preclinical testing
WuXi AppTec’s new lab in Munich brings a deep technical expertise and will address a critical issue in preclinical testing: limited capacity is causing a significant bottleneck for medical device manufacturers. The demand for efficient and rigorous preclinical testing has outpaced existing lab capacity. This new lab will help address that shortfall, reduce delays, and ensure regulations are met.
In the future, WuXi AppTec will continue to expand its leadership in the industry as it drives future innovation in lab testing.
A final word
Extractables/leachables testing is often a crucial component when evaluating the biocompatibility of medical devices. With our new lab opening in Munich, Germany, we are now bringing our expertise directly to Europe. While we have been supporting European customers from our U.S. lab, this expansion allows us to offer more localized and responsive services, better supporting their needs in compliance with the European Union’s Medical Device Regulation (MDR) and the relevant ISO and USP standards.
