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The recent growth of self-administration devices has provided the opportunity to truly change the landscape in drug delivery. These devices, such as auto-injectors, not only allow for more patient convenience, but also enable different dosing regimens and types of therapies that can now be injected via auto-injector. These advantages are why the auto-injector segment is the fastest growing delivery segment, and the majority of top selling drugs are delivered via PFS/auto-injector.
Pharmaceutical closures used in aseptic environments must be introduced in a sterile state. The most common methods to sterilize rubber closures (e.g., stoppers) are autoclaving (saturated steam) and gamma irradiation. Both methods can influence chemical (e.g., extractables profile) and physical/functional properties (e.g., break-loose and extrusion forces). Therefore, it is important to choose the right method.
Ensuring the sterility of medicinal products has always been one of the key concerns of drug manufacturers, due to the dire health implications it could have on patients, as well as the potential for costly product recalls. The importance of control strategies to ensure drug products remain sterile has also been reiterated recently by regulatory agencies such as the U.S. Food and Drug Administration (FDA) and The European Medicines Agency (EMA) in their respective guidelines:<br /><ul><li>FDA: Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice</li><li>EU GMP Annex 1 Manufacture of Sterile Medicinal Products</li></ul>
As scientists continue to gain a better understanding of the Corona virus, we are witness to a growing number of novel and repurposed therapeutics in development along with clinical trials designed to attack multiple aspects of the unique clinical pathologies. On the vaccine side, manufacturers are trying a multi-pronged approach to stimulate the immune system by using both traditional approaches (i.e., protein subunits, inactivated viruses, and virus-like particles) and novel platforms that are based on delivery of mRNA, DNA, or non-replicating viral vectors that can trigger the body to make the viral proteins themselves. The typical timelines, not counting the time it takes to demonstrate safety and efficacy of these vaccines, can range from months to years and even up to a decade to successfully design, manufacture and consistently produce high quality vaccines.
West’s Kinston, NC facility was recently recognized with an Honorable Mention at the 2016 International Society for Pharmaceutical Engineering’s (ISPE) Facility of the Year Awards’ ceremony on June 7, 2016, in Bethesda, Maryland. The award acknowledged the West team’s creativity and innovation during the Ready-to-Sterilize (RS) Expansion project, which was completed in June 2015.
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