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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.
<p><span>Anti-VEGF therapeutics for the treatment of ophthalmic conditions such as neovascular (wet) age-related macular degeneration (AMD) and diabetic macular edema (DME) have significantly improved patient prognoses, in some cases preventing or reversing progression to blindness. Routine injections into the eye of recombinant protein drugs such as bevacizumab, ranibizumab or aflibercept have proven to be efficacious in neutralizing the binding of over-expressed vascular endothelial growth factor (VEGF) proteins to their corresponding cellular receptors, thus interrupting the angiogenesis signaling pathway which otherwise leads to the disease states. In short, anti-VEGF injections are preventing or restoring vision loss for millions of people world-wide.</span></p>
Natural Rubber Latex (NRL) has been a topic of concern in the pharmaceutical industry since the early 1990s. Concerns with allergens prompted labeling guidelines to ensure safe patient treatment. West Pharmaceutical Services’ elastomeric formulations for injectable packaging components for vials and syringes may contain Dry Natural Rubber (DNR) in the form of crepe, but the formulations do not incorporate NRL.
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.
The future is now for parenteral pharmaceutical and biopharmaceutical sterile production. Traditional high-volume automated aseptic filling suites are maintained by contract filling services. But what’s emerging? Parenteral pharmaceutical and biopharmaceutical industries have transitioned to fully enclosed, isolator/restricted access barrier (RAB) systems. These small, efficient systems offer cost savings and can reduce the potential for particulate and microbial ingress during aseptic fill/finish manufacturing by eliminating direct human contact in the filling environment.
West is proud to announce that Diane Paskiet, Director, Scientific Affairs will serve as Co-chair at the upcoming PDA Packaging Conference in Baltimore, MD. In her leadership role for the meeting, Diane will moderate several sessions, including <em>Repackaging – Problems and Solutions</em> and <em>The Future Direction of Devices and Patient Adherence/Compliance</em>.