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Our vision for the West Knowledge Center has always been to deliver a digital platform full of the most cutting-edge science and product information to further support our customers and potential customers in their search for packaging and device solutions and services. But what about individuals who are new to the industry? Where do they go to gain a strong foundation in these areas to figure out exactly what they need?
The answer is…our West Learning Center. As part of our ongoing effort to remain a valuable resource for our users, we have added a new section of the Knowledge Center with the goal of further helping our customers and potential customers gain an understanding of topics related to packaging and delivery systems, starting with the most basic and advancing to expert level information.
The first level of our curriculum, “Parenteral Drug Packaging and Delivery Systems 101,” has been officially published and can be found here. You will find a series of presentations with basic information on various topics, including:
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Be sure to check back often as we continue to add courses and materials throughout the year that will offer information on a breadth of industry topics. We believe that knowledge is power, and through our Knowledge Center, we aim to remain a valuable resource for our partners during their journey of choosing packaging and delivery systems and services that are most appropriate for their injectable drug products.
If you are not yet a Knowledge Center user, we encourage you to register here to gain access to insightful information on a variety of industry topics. If you are a current customer, don’t forget to check the ”Customer level access” box to be automatically approved for our second level customer portal, where you will find many of your technical product documents.
NovaPure®, Envision™ and AccelTRA® are trademarks and registered trademarks of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
Modern biopharmaceutical drug molecules are often complex protein structures that need to maintain the molecular structure in order to convey full potency. With biologics, any alteration of the 3-D structure could lead to loss of activity or even to immunogenic reactions in the patient. Proteins can be disrupted by interactions with the container closure or with leachables. West FluroTec® lamination was chosen for NovaPure® plungers to reduce the interaction between the drug product and elastomer material. This includes less adsorption to the plunger surface as well as reduction of the leachables profile of the plunger, helping to maintain the stability of complex molecules.
As regulatory expectations increase, drug product manufacturers face increased pressure to produce products free of defects and minimize rejects of finished drug products. Particulate matter in finished pharmaceuticals can come from a number of sources, including the ingredients in the drug product, manufacturing equipment or the container closure system.
<p>There have been many innovations over the past century since it was first shown that insulin injections could help control chronic diabetes. Advances in hardware and software have resulted in more accurate blood glucose sensors that work via less invasive means and insulin pumps that have become smaller and ever more sophisticated. As we discussed in our <a href="/blog/2017/july/growth-in-glp-1-drugs-may-offer-improved-outcomes-to-people-with-type-ii-diabetes">last blog</a> [1], there are also newer drugs, that when combined with traditional insulin therapy, can help patients better control the blood glucose levels.</p>
When it comes to filing time, the last thing you need is a surprise. The pharmaceutical industry focus on issues of extractables and leachables (E&L) from packaging/delivery systems began during the mid-1990s. Since then, regulatory agency awareness of these issues has increased, while drug product formulations and other drug product contact materials have become more complex. When agency questions on extractables and leachables do arise, the process to evaluate them can seem overwhelming. As a result, many customers are asking: “Do I really need to complete all of the testing requested?”; “What does West already know about the elastomer formulation I am using?” or “Where do I start?”
The environment for developing an injectable drug device combination product (CP) is dynamic from a regulatory and technical perspective. At the center of it all are the patients and their needs. West is pleased to announce the publication of its review manuscript that provides a detailed overview of best practices for this kind of development program. It considers technical and regulatory aspects and can be used as a foundational document for drug formulators, scientists and engineers working in this area.
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