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In the latest installment of our video series, West on the Road, we travel across the Atlantic to our manufacturing facility in Eschweiler, Germany. There we meet Manager of Process Engineering Martin Rothstein, who says he’s impressed at how often he has encountered West products in his private life, whether visiting a family member in the hospital or during a vaccination appointment for one of his two small children.
Rothstein and the teams at the Eschweiler facility produce high-value pharmaceutical packaging products, turning materials into high-quality elastomeric stoppers, plungers and other components for the biotech and pharmaceutical industries. With the biopharmaceutical industry experiencing a shift toward patient-centered, quality care, it is increasingly important to maintain strict manufacturing processes to decrease risk. With this in mind, Rothstein explains that for many customers, it’s important to work with a provider such as West that manufacturers all of the various packaging components for a drug product under one roof, ensuring minimal risk.
The teams at Eschweiler have a long history of providing high-quality components; they possess a deep knowledge of the production process and are able to provide the right support to the customers to help them improve patient care around the world. Check out this new video to learn more about the work being done at West’s Eschweiler facility and visit our Careers page to learn more bout working at West in Germany.
<p>Amy Miller and Jennifer Riter</p><p>Extractables from elastomeric components become an issue even before a pharmaceutical drug makes contact with the elastomeric component. The suitability of the elastomer and the drug product needs to be taken into consideration at the development stage of the packaging and delivery system for the drug product. The potential for an extractable to leach into the drug product and the impact that leachable will have on the drug’s stability, efficacy and toxicity needs to be scientifically evaluated. </p>
<span>Recently, members of West and the University of the Sciences in Philadelphia, PA celebrated the 20<sup>th</sup> anniversary of the West Center for Computational Chemistry and Drug Design.</span>
Pharmaceutical industry focus on issues of extractables and leachables from packaging/delivery systems began during the mid-1990’s. Since then, regulatory agencies have become more educated, and drug product formulations have become more complex, which makes the need for a robust extractables and leachables program that much more critical. Failure to properly evaluate extractables and leachables has had a negative impact on many pharmaceutical companies, e.g., late-stage stability failures, submission delays, and recalls. To avoid this, the question is – where to start?
Since the 2012 New England Compounding Center tragedy that linked a deadly fungal meningitis outbreak to a failure to use current good manufacturing practices (cGMP),<sup>1</sup> compounding pharmacies have faced increasing scrutiny and regulation by the U.S. Food and Drug Administration (FDA). While registering with the FDA is still voluntary, only compounding pharmacies that register, and pass inspection, will be granted “503B” status as compounding outsourcing facilities under Section 503B of the Federal Food, Drug, and Cosmetic Act.<sup>2</sup>
Amy Kim
Sr. Specialist, Scientific Communications, SA & TS