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West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration, today announced expanded Analytical Services capabilities to address the areas of greatest challenge to the industry concerning packaging, delivery and combination product needs. The new capabilities include the addition of technical experts in several focus areas, equipment and new technology to help West customers navigate ever-changing global regulatory and quality demands.
“To ensure that therapies are coming to market safely and effectively, it’s critical that our customers have the needed data and insights to thoroughly examine the compatibility between a therapy and its primary containment and delivery technology to mitigate potential risk to patients and help them move more easily through development,” said Jennifer L. Riter, Sr. Director, Analytical Services, West. “Through these expanded Analytical Services capabilities, combined with West’s extensive knowledge of industry standards and ability to customize testing based on regulatory needs, we can continue to help simplify our customers’ journey from development through commercialization.”
An example of some of the newer equipment is an ion mobility quadrupole time of flight mass spectrometer (Q-ToF), which allows for both separation and selectivity by combining chromatography, ion mobility and mass spectrometry for enhanced extractable and leachable analysis. Additionally, to address the growing demand for deterministic Container Closure Integrity (CCI) analysis, a new oxygen headspace analyzer was acquired to be able to address CCI needs with several packaging and delivery systems. Lastly, West Analytical Services has incorporated many ISO performance testing methodologies to assist its customers with qualifying and evaluating their drug product with various packaging, delivery and combination products as they transition from molecule to market.
“Customers can mitigate risk by combining these enhanced capabilities with West’s Analytical Services expertise and experience in extractables and leachables, particle analysis, CCI, and packaging and delivery system performance, among other methodologies,” continued Ms. Riter. “In addition, West’s deep understanding of materials and delivery systems combined with the ability to analyze drug product compatibility enables the ability for a unique partnership from early development throughout lifecycle management.”
West Analytical Services can assist global pharmaceutical companies in designing studies to understand the specific needs of complex, sensitive therapies and navigate the challenging and evolving regulatory landscape to both safely and efficiently bring innovative therapies to market. The labs are GMP and FDA compliant, DEA licensed, certified to ISO 9001:2008 and ISO 15378:2011, and have two MHRA certificates.
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