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Ever wondered what West’s cutting-edge product development facilities look like on the inside? Jeff Kyle, Sr. Director New Product Introduction, and Tom McLean, VP Delivery Systems R&D, take you behind the scenes of the Scottsdale, AZ plant.
In addition to exploring new products and custom packaging design, the Scottsdale plant manufactures the Crystal Zenith® Ready-to-Use Insert Needle Syringe System, and the SmartDose® electronic wearable injector. West recently expanded the Scottsdale facility to accommodate customer demand for the SmartDose electronic wearable injector, Kyle explains in this clip, including bringing it up to ISO 7 cleanroom standards. That certification – and the tight layout of the assembly floor – helps employees create the systems more efficiently.
Moving to the lab, Jessica Wentzel, Microbiology Lab Manager, demonstrates the rigorous testing that incoming raw materials and Daikyo Crystal Zenith® cyclic olefin polymer components undergo, from a microorganism and endotoxin standpoint.
As McLean points out, West’s state-of-the-art technology and complex production protocols are put in place for one thing: Enriching patient safety. It’s this element of creating pharmaceutical integrated containment and delivery systems for injectable medicines that inspires pride among West employees.
Daikyo Crystal Zenith® is a registered trademark of Daikyo Seiko, Ltd. Daikyo Crystal Zenith® technology is licensed from Daikyo Seiko, Ltd.
SmartDose® is a registered trademark of Medimop Medical Projects Ltd., a subsidiary of West Pharmaceutical Services, Inc. West seeks partners for its SmartDose® injector technology platform. This platform is intended to be used as an integrated system with drug filling and final assembly completed by the pharmaceutical/biotechnology company.
Join our subject matter experts in Boston for the 2013 Educational Series, “Supplying Safe Medicines to Patients: Considerations for Container Closure and Delivery Systems.”
The plunger rod is a fundamental feature of a complete syringe drug delivery system. There are three key functional characteristics that all pharmaceutical manufacturers should consider when determining the appropriate plunger rod for a specific drug product and syringe system.
The development of a drug product is an arduous and intricate process. Besides ensuring the sterility and effectiveness of the final product, it should also be as free of particles as possible. In protein-based pharmaceuticals, aggregates may form over time and are mostly detrimental to product quality, as they can affect the efficacy, potency, clinical safety, and immunogenicity of the product.<sup>1-3</sup> Protein aggregates are considered a type of particulate matter (PM), and it is important to minimize their occurrence, as well as to quantify the PM for ensuring the quality and safety of the drug products.
The number of people fleeing from war to seek refuge in Europe is increasing every day. Many people arrive with harrowing tales of overcoming long distances carrying small children in their arms, having nothing but the clothes on their backs.
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. Through the Integrated Solutions platform, West is ideally positioned to provide this data.
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