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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.
On August 6 and 7, 2019, USP hosted the Second Annual Workshop to explore current trends, initiatives and regulations for quality compounding. Members of the West Pharmaceutical Services, Inc. (West) Scientific Affairs and Strategic Marketing departments participated in the USP workshop and gained valuable insight into the key elements of the FDA’s efforts to improve the quality of compounded drugs.
<span style="color: #333333;">Today, we are more connected than ever before. We rely on the Internet to stay informed and to perform our day-to-day jobs. It’s hard to imagine our lives without the Internet; yet for all of its advantages, increased connectivity brings increased risks for cybercrime. Recognizing the importance of cyber security, President Obama designated October as National Cyber Security Awareness Month (NCSAM), as has the European Network and Information Security Agency (ENISA). At West, we are committed to ensuring the ongoing success of our business processes and operations, which requires information that is accurate, complete, consistent and, above all, secure. This makes cyber security one of West’s most important priorities.</span>
Few topics generate as much interest as the reduction of drug manufacturing end-of-line rejects, which is one of the clearest and easiest ways to reduce waste and maximize operating profit and may help improve patient safety. One of the largest contributing factors to the end-of-line reject rate is the quality of the packaging components selected for the drug product.
Research in the area of cell and gene therapies started almost 40 years ago, however recently there has been a been a surge of activity including landmark regulatory approvals for therapies treating chronic and rare diseases. In 2017 and 2018 the FDA approved the first two CART-T cell therapies for cancer treatment and the first two gene therapies for rare diseases. All four of these cell and gene therapies were approved under the FDA Accelerated Approval Program, aimed at expediting approvals for life saving drug therapies. These regulatory programs have the potential to shorten drug development as much as 1-3 years. Currently, there are more than 1,000 regenerative medicine clinical trials underway globally<sup>1</sup>, and the market is expected to grow rapidly over the next 10+ years.
Compendial documents developed by both international and national organizations outline specifications for elastomeric components that are used in packaging of parenteral drug products. These specifications often are not harmonized; not all compendia specify the use of the same tests, and some tests that are used globally have varying specifications. Understanding these specifications and how they influence packaging/delivery of parenteral drug products in global markets is critical.