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The following is an excerpt of an article that appears in the Summer 2014 edition (Vol. 6, Issue 2) of International Pharmaceutical Industry magazine. To read the complete article, which begins on page 92 of the issue, visit: http://issuu.com/mark123/docs/ipi_-_volume_6_issue_2_june_2014
Development of therapeutic proteins has been on the rise for a variety of disease conditions. The administration of parenteral biologics relies on interconnected attributes associated with compatibility of delivery components to the safety and efficacy of the final product. It is essential to characterise individual components in contact with a biologic to understand the risks to the delivery system as a whole and the effect on patient outcome. Selecting an appropriate delivery system for these therapies is critically important. The quality of the components within a delivery system also has a significant impact on the development efficiency and the time to market. There are unique regulatory expectations as well as physical and chemical aspects that need to be considered when choosing components for a delivery system. Adequate information on user needs is necessary to design a delivery device suitable for intended use. Quality considerations are important throughout each phase of the pharmaceutical lifecycle to assure fitness for intended use relevant to patients. Alignment of the delivery device with the biologic manufacture, storage and distribution processes is a key element for bringing a product to market.
The number of biologic drug products marketed with an injection device has approximately quadrupled over the last decade. The growth in these drug therapies has been driven by several factors including new, self-administered therapies for chronic conditions such as rheumatoid arthritis and autoimmune diseases. In addition, injectable therapy is now being considered as a treatment for more conditions, including asthma and cholesterol problems.
The recent growth of self-administration devices has provided the opportunity to truly change the landscape in drug delivery. These devices, such as auto-injectors, not only allow for more patient convenience, but also enable different dosing regimens and types of therapies that can now be injected via auto-injector. These advantages are why the auto-injector segment is the fastest growing delivery segment, and the majority of top selling drugs are delivered via PFS/auto-injector.
In order to ensure the best quality drug product and optimal patient outcomes, it’s important for drug manufacturers to foster a collaborative effort with their packaging suppliers from the beginning – and that means starting with the patient in mind. Understanding patient needs and how that drug will be delivered, whether through one of West’s delivery devices or some other device, will help determine the needs within the West manufacturing process.
Join West’s Graham Reynolds as he presents the keynote at Pharmapack North America. Graham will present, “<em><strong>Understanding the regulations and safety concerns surrounding injectables to overcome inherent design challenges” </strong>on </em>Wednesday, May 23, 2012 at 1:50 pm. The conference will be held at the Pennsylvania Convention Center, Philadelphia, PA on May 22-23.
Combination products open up new vistas when it comes to delivering innovative therapies to patients in need, but teams bringing these products to the market face a number of significant hurdles. Recent surveys conducted by West at workshops held in PA and AZ have revealed some of our customers’ biggest challenges. This is the second of three blogs focused on these challenges — and how West can help Simplify the Journey™ when it comes to developing a combination product.
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