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Development of vaccines for COVID-19 and its variants continues to present challenges such as accelerated timelines. Since there is not the usual time available for selection, evaluation, and qualification of the package and delivery systems, risks must be mitigated at every phase. For vaccines packaged in prefilled syringes, use of an elastomer plunger laminated with FluroTec® film can help.
FluroTec film, based upon poly(ethylene tetrafluoroethylene), has properties that both reduce migration of leachables into the vaccine and reduce interaction with the vaccine. Moreover, plungers with FluroTec film enable consistent delivery volume and break-loose and glide-force performance over a range of viscosities. These features are discussed in a new report by West scientists: Elastomer Plungers with FluroTec® Film: The Right Choice for COVID-19 Vaccines.
Leading vaccine manufacturers already have chosen FluroTec films for their elastomer stoppers. Offered exclusively by West and Daikyo Seiko, Ltd., components with FluroTec films are globally available and have a decades-long record of use with a variety of molecule types (over 130 approved by FDA/EMA). Plungers with FluroTec film are offered in 1 mL and 1-3 mL formats. They are clearly the lowest risk choice among West and Daikyo plungers and can help mitigate development and compatibility risks in bringing a COVID-19 vaccine to market.
Download the whitepaper by clicking the button below:
FluroTec is a registered trademark of West Pharmaceutical Services, Inc, in the United States and other jurisdictions.
FluroTec technology is licensed from Daikyo Seiko, Ltd.
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.
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.
In the prefilled syringe system, the plunger is in contact with the drug product during administration and the drug storage period, which may last up to two years and can affect the long-term stability of the drug product.<br />
One of the challenges of sharing technical content is making the material engaging and easily digestible to many different types of learners. It must not only be scientifically accurate, but also needs to capture and keep the attention of the intended audience. The Knowledge Center on West’s website is a valuable repository of written and presented materials, created by the experts who develop and test our products. It is also now home to the Learning Center, a section of the Knowledge Center that shares information on a more introductory level, aimed at new employees or companies that are new to packaging. In an effort to continue enhancing our website content, we are now also starting to add new types of media. In the age of podcasts and vlogs (video blogs), we understand that video and audio are just as helpful (maybe more so!) for people trying to grasp a new concept.
Beginning in 1998, when an increase in the incidence of pure red cell aplasia (PRCA) was observed in patients with chronic renal failure and associated with the subcutaneous use of Eprex<sup>®</sup> (epoetin alpha), the U.S Food and Drug Administration (FDA) and European regulatory agencies have paid special attention to leachables in drug products especially resulting from uncoated primary elastomer components.
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