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In Part 1 of our West on the Road – Eschweiler series, we learned about the high-value products produced in our Eschweiler, Germany facility and how this dedicated team of manufacturing experts supports customers in their mission to bring critical medicines to patients. In Part 2, we learn from Lukas Buglowski, Team Lead of Engineering, Envision, about how a focus on quality is both a shared mindset and built into every step of the manufacturing process in Eschweiler. Buglowski shares the pride his team feels knowing that they are producing high-quality products that will not only meet customers’ expectations, but more importantly, ensure patient safety, and how this builds trust and makes for a great team dynamic.
We also learn from Manager of Process Engineering Martin Rothstein about another pride-boosting element about working at Eschweiler: the fact that teams are plugged into and collaborating with West’s global network, regularly providing support to other manufacturing plants around the world. Check out this latest video to see the Eschweiler team in action.
Diane Paskiet, Ph.D., Director of Scientific Affairs, will present “Biopharmaceutical Quality: Factoring Extractables into the Risk Equation” at Cambridge Health Insitute’s 14<sup>th</sup> Annual PepTalk 2015 conference on January 22-23, in San Diego, CA. The program, which was co-developed by Thomas Egert, Research Scientist, Boehringer Ingelheim GmbH & Co. KG, will focus on risks to quality posed by materials that contact biologics during manufacturing, storage and those associated with the final packaging configurations can pose risks to quality.
When it comes to choosing the right container closure system, a significant amount of focus is directed at addressing issues that may be a risk to safety and efficacy of the parenteral drug before it is introduced to a patient. Examples are testing of container closure integrity (CCI) and drug stability. Prior to drug administration by a health care professional, the rubber stopper is pierced with a needle, at least once. Stopper puncture testing also needs to be considered, especially if the closure system will be used in a multi-dose application.
As cell therapies are making their way to the market, safe and efficient transfer/delivery presents a challenge. Needles and syringes are commonly used to retrieve cell therapies from vials, posing the risk of needle stick injury. To address this, West has evaluated the suitability of its needle-free polycarbonate vial adapters (VAs) for withdrawing contents from vials from both a compatibility and performance standpoint.
<span>West is pleased to announce that it has joined the Pharmaceutical Supply Chain Initiative (PSCI). PSCI is a group of major pharmaceutical companies, all of which are West customers, that formed to “support pharmaceutical suppliers in efforts to operate in a manner consistent with industry expectations about ethics, labor, health and safety, environment and management systems.” PSCI members believe that through the application of principles for responsible supply chain management, better social, economic and environmental outcomes will result for all involved in the pharmaceutical supply chain. This includes improved conditions for workers, economic development and a cleaner environment for local communities.</span>
Every pharmaceutical company wants to maximize speed to market for a new drug product. One way to enable this is with a platform approach for the package and delivery systems – in other words, to use the same vial containment system and/or syringe system for multiple drug products. To use this approach effectively, component and system performance data is needed. West, through the Integrated Solutions platform, is ideally positioned to provide this data.
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