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<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>
Particles in parenteral drug products have been a major source of product recalls in recent years (>100 from 2010-16). They are especially problematic for biologic drug products, where they can induce formation of protein particulates that may have immunogenic effects.
Employees from The Tech Group’s Phoenix, Rockford, Scottsdale and Tempe West facilities raised more than $72,000 for Upward Children and Families as part of the 2013 West without Borders fundraising campaign.
In its 95+ year history, West has developed and marketed a very large number of elastomeric formulations, each designed to address particular market demands. Over this time, various aspects of drug product quality have gained attention – a fact reflected in the numerous regulatory guidances that have been issued. An early focus of these guidances was extractables and leachables, followed closely by particulate matter and container closure integrity. Beyond these regulatory requirements, the market demands product portfolios that enable platforming and predictable, consistent product quality and performance.
West has been busy behind the scenes building our offerings in the West Knowledge Center. The Knowledge Center launched just over a year ago, and since then we’ve more than doubled our content based on customer requests and real-time data and analytics.
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