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Patient safety is defined by the Institute of Medicine as: the prevention of harm to patients.1 The extension of this principle to general safety in healthcare is: the freedom from accidental injury, and it applies not only to patients, but to all professionals and workers in the healthcare field.2
Managing such a complex scenario includes, among other things, the standardizing and simplifying of equipment, supplies and processes. In particular, ensuring the safe containment of sensitive drug formulations, and allowing safe drug administration at the point of care, relies very much on the container closure and delivery systems. West is committed to the safe and efficient delivery of drug products to patients. Achieving this commitment has many facets, among which are:
These, along with many other points, in collaboration with Technical Customer Support (TCS), enable customers to simplify a complex scenario and make the best selection of products for the safe containment and delivery of drug products. For more information, contact a TCS representative.
FluroTec™ and NovaGuard™ are registered trademarks of West Pharmaceutical Services, Inc., in the United States and other jurisdictions. FluroTec™ technology is licensed from Daikyo Seiko, Ltd.
SmartDose™ is a registered trademark of West Pharma. Services IL, Ltd., a subsidiary of West Pharmaceutical Services, Inc.
Lyophilization (freeze drying) is the process of dehydrating a material at low temperature and reduced pressure. It is used to extend the shelf life of many biologic drug products. Absent water, degradation processes are greatly reduced. In any primary package system (i.e., vial, elastomer stopper, seal) for a lyophilized drug product, of utmost concern are leachables and volatile organic compounds that may migrate from the elastomer stopper into the lyophilized drug product, creating a risk to patient safety.
<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>
Biologic drug products are not new – their development began decades ago; the first monoclonal antibody was commercialized in 1986.<sup> [1]</sup> With the increasing availability of genetic information, and better understanding of subcellular cascades and disease processes, the number of biologic drug products available has increased substantially in response to an exponential growth in targets. <sup>[2]</sup>
At West, our focus is on supporting the biopharmaceutical industry in qualification and commercialization of containment and delivery systems for injectable medicines. <span></span>Selecting high-quality drug packaging that meets regulatory standards is essential to a drug manufacturer’s success. <span></span>West’s top priority is delivering high-quality packaging products that meet the exacting quality standards and product specifications customers require.
Developing a SARS-CoV-2 vaccine presents numerous and unprecedented challenges; prominent among them are greatly accelerated timelines. Ordinarily for a new drug product, there is sufficient time for selection/evaluation of the vial/stopper packaging system – one that guarantees quality and safety from manufacture through delivery. This is not the case for a SARS-CoV-2 vaccine where the primary packaging system must be chosen quickly, creating a higher risk.
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