West Pharmaceutical Services, Inc. has expanded Analytical Services capabilities to help address industry challenges 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 customers navigate ever-changing global regulatory and quality demands.
 
The new equipment includes 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 help address CCI needs with several packaging and delivery systems. Lastly, the company has incorporated ISO performance testing methodologies to assist customers with qualifying and evaluating their drug product with various packaging, delivery and combination products as they transition from molecule to market.

“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, senior director, Analytical Servcies, 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.”

West Analytical Services labs are GMP and FDA compliant, DEA licensed, certified to ISO 9001:2008 and ISO 15378:2011, and have two MHRA certificates.