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Drug shortages put patients at risk. Adverse health consequences can occur quickly when shortages make maintaining and/or complying to a therapeutic regimen difficult. In a recent paper, Center for Drug Evaluation and Research (CDER) director, Janet Woodcock and her CDER colleague Marta Wosinska offered insight into the challenges CDER faces in choosing a course of compliance action when shortages of critical drugs occur. In the paper, CDER officials cited quality issues as the largest cause (56 percent) of drug shortages in 2011.
In a market that does not “reward” quality, which as in all industries, tends to come at a higher price, drug manufacturing companies may choose to minimize quality-related investments that can make a difference in the overall efficacy of their drug product. Areas such as maintenance of production facilities and equipment, quality control testing and preventive actions on early indications of quality problems may not receive the investment needed to help ensure high quality.
In addition, many customers assume that quality has been “regulated” into the drug product, and base purchase decisions on price alone.
But as the old saying goes, you get what you pay for.
West provides a variety of options to help ensure that quality requirements are met. Product selection should be made based on the needs of the end-user and the needs of the drug product itself. Westar® Ready-to-Use (RU) component processing provides an excellent option for drug product manufacturers seeking to place the regulatory burden further upstream. Doing so will shift risk to the component manufacturer.
Additional options, such as West’s EnvisionTM 100-percent vision verification process, also may help to increase quality by reducing end-of-line rejections. For biologics and sensitive drug products, West offers high-quality NovaPure® components, which provide consistent, reliable, high quality through a product development process that incorporates Quality by Design principles.
How does West respond to increased demand to produce supplies needed for use with treatments to combat the coronavirus? The answer is – with years of experience, careful planning, and a robust manufacturing program. We are committed to doing our part to speed the successful development and large-scale manufacture of high-quality components required to serve customer needs for the delivery of a safe, effective COVID-19 vaccine, which includes expanding labor and equipment resources.
Manufacturers of sterile drug products have a long history of receiving elastomeric plungers for use in a prefilled syringe in a sterilized, ready-to-use (RU) condition. This trend has more recently evolved to include other container closure components including, glass or plastic vials, aluminum over seals and elastomeric stoppers. When accepting RU components into a new or existing manufacturing process, it is important to consider how sterility assurance of the components will be determined.
Vial adapters are easy to use and pose less risk of needlestick injury than traditional syringe and needle manipulation. They not only provide needle-free transfer of liquid for reconstitution, but also enable consistent withdrawal of drug product from a vial. By providing such consistent withdrawal, the use of vial adapters can aid in reducing the amount of required overfill (extra drug product in a vial to address the fact that not all drug product can be removed), which may result in cost savings.
The recent Pharmapack meeting in Paris provided a great global overview of the latest in pharmaceutical packaging and delivery. This meeting involved not only the traditional tradeshow, but presentations from pharmaceutical and biotechnology companies as well as from companies offering packaging and delivery systems.
With the advancement of high-value biologic,<span> gene, and cell therapy drugs, there is a growing interest in assessment of container closure systems (CCS) at the low temperatures experienced during processing, storage, and shipment. A vial-based CCS is usually capped at room temperature, but thereafter it may be exposed to low temperature conditions (0<sup>o</sup>C to -180<sup>o</sup>C), depending on both the drug characteristics and the expected duration of storage. </span>
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