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Extractables and leachables (E&L) remain as one of the hottest topics in China – a topic to which West makes a strong commitment – in order to anticipate and address ever-changing regulatory and technical requirements. As part of this commitment, Lynn Yao, Scientific Affairs Manager at West, presented Challenges of E&L Study Under Changing Regulatory Environment at the second-annual Extractables and Leachables China, hosted by Smithers Rapra, September 2019 in Shanghai. This event assembled local stakeholders and experts for two days of presentations, training, and discussion on the China regulatory landscape, testing methods, and technical advances.
She shared West’s up-to-date knowledge on regulatory requirements and West’s comprehensive experience regarding E&L, specifically on four aspects of elemental impurities:
It was emphasized that to address these aspects careful monitoring and understanding of the regulatory requirements is needed first. Second, a risk-based approach with a holistic understanding of potential sources of elemental impurities regarding, in particular, components and systems is needed.
Selection of the right components is critical. Through Technical Customer Support (TCS) and the Integrated Solutions program, West can not only advise on proper selection, but design and execute the studies needed to support regulatory compliance. For more, contact a TCS representative or Account Manager.
<p>Tibor Hlobik, Director, Prefillable Solutions and Technologies<br />Mike Gills, Customer Technical Support Process Engineer</p><p>Growth in biopharmaceutical therapeutics is leading innovation with prefillable syringe systems. These complex sensitive drug products require highly inert primary packaging materials for improved stability and delivery in perfect quality for reduced safety risk. This <span style="text-decoration: underline; color: #0000ff;"><a href="https://www.westpharma.com/west-login">poster</a></span> will provide a quality comparison of primary prefillable syringe options including glass, coatings/laminates and cyclic olefin polymers, and highlight the findings of a case study comparing 1mL long syringe attributes.</p>
Designed to help improve consistency and reliability of intradermal inject.
West today announced a multi-year investment as part of the Company’s evolving research and development strategy. To better support pharmaceutical customers around the world, West will add capabilities to all of its global Packaging Systems R&D facilities, and develop two new R&D Centers of Excellence—one in the Asia Pacific region and one in Europe—to leverage regional capabilities and expertise in parenteral drug packaging.
In 2014, the West Women Investing and Networking (WIN) initiative was born under the leadership of Karen Flynn, Sr. VP & Chief Commercial Officer, and a group of female employees at the West U.S. headquarters in Exton.
West is honored to be a recipient of the 2020 Faces of Philanthropy Award from the Philadelphia Business Journal. The Faces of Philanthropy Awards honor partnerships between corporations and nonprofit organizations in the Philadelphia region as they work together to deliver impactful philanthropic initiatives.
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