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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.
This risk can be mitigated by selecting the best performing stoppers, namely stoppers with FluroTec® film. This is discussed in a new report by West scientists: Elastomer Stoppers with FluroTec Film: The Right Choice for SARS-CoV-2 Vaccines.
Employing the chemical properties of fluoropolymers, stoppers with FluroTec film: (1) reduce migration of leachables, (2) reduce interaction with drug product, and (3) enable excellent container closure integrity at low temperatures. Globally available and market accepted, based upon West analyses, they are FDA/EMA approved for over 125 drugs, including three vaccines and 30 novel drugs. Available in multiple formats and sizes (serum/lyophilization, 13/20mm), they can accommodate a variety of vaccine formats (currently six are in development). Taken altogether, stoppers with FluroTec film are clearly the best choice, and enable the lowest risk, for SARS-CoV-2 vaccine package systems.
For more information, contact an account manager or Technical Customer Service (TCS) representative.
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.
We recently sat down with Dr. Bettine Boltres, our contact for scientific affairs and technical solutions for glass. In her role she is supporting pharmaceutical companies to address glass-related topics from a scientific perspective and to gain a deeper understanding of the material that holds their valuable drug products. Having done this for many years, we wanted to know what the most frequently asked questions are that she encounters. Please read Part 1 of our two-part series around the 10 most commonly asked questions around glass vials:
Combination products open up new vistas when it comes to delivering innovative therapies to patients in need, but teams bringing these products to the market face a number of significant hurdles. Recent surveys conducted by West at workshops held in PA and AZ have revealed some of our customers’ biggest challenges. This is the second of three blogs focused on these challenges — and how West can help Simplify the Journey™ when it comes to developing a combination product.
<span>Before an injectable biologic can be formulated and manufactured, an extensive series of pre-formulation checks are necessary to ensure that developers avoid formulating an unstable, non-viable product¹. Developers must determine whether the injectable biologic will break down within the intended formulation or the manufacturing process. The drug must be thermally stable, possibly resistant to oxidation, tolerate variations in light, and other environmental stresses placed on it during manufacturing and packaging.</span>
Drug delivery via cartridge-based systems has been around for many years, with traditional applications being for the dental and insulin markets. These traditional markets will continue to maintain much of the volume for cartridge-based systems in the future; however, there is an increasing trend toward other therapeutic classes of drugs, such as those that treat auto-immune diseases, that never used cartridges before. This trend, along with the projected growth in the insulin market, indicates substantial overall growth in the cartridge space over the next several years. This Blog discusses the issues driving these trends and the West product portfolio in the cartridge market.
During the week of June 24 – 28, the West Ambassador Interns had the opportunity to mentor a group of high school seniors from the Downingtown S.T.E.M. Academy. The students were participating in a practicum at West as a requirement for graduation. During the week, each intern was assigned a S.T.E.M. student who shadowed the interns’ daily activities. We taught them about our respective departments and the responsibilities we have as part of the West team. The students also received lab tours and participated in a telepresence Lunch and Learn with the Scottsdale, Ariz., facility to learn more about West and its products.
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