West Pharmaceutical Services, Inc. has expanded its analytical services capabilities to address 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 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, senior director of analytical services at West Pharmaceutical.
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. In addition, a new oxygen headspace analyzer was acquired to address Container Closure Integrity (CCI) needs with several packaging and delivery systems.
The company also incorporated ISO performance testing methodologies to assist clients in qualifying and evaluating their drug products with various packaging, delivery, and combination products as they transition from molecule to market.
West reports that its analytical services labs are GMP and FDA compliant, DEA licensed, certified to ISO 9001:2008 and ISO 15378:2011, and have two MHRA certificates.
(Source: West Pharmaceutical Services, Inc.)
