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The need to provide vaccines for the SARS-CoV-2 pandemic has presented the pharmaceutical industry with unprecedented challenges. Among them are accelerated timelines for development/approval and unanticipated volumes for manufacture/delivery. Ordinarily for a new drug product, there is ample time for selecting the primary package system and establishing component availability.
This is not the case for SARS-CoV-2 vaccines, so to quickly meet expected demands, risks must be minimized in every aspect. One of these aspects is availability of package system components, in particular vials. Traditionally, glass vials are used for vaccines; however, the unanticipated volume demand creates the risk of shortages.
To minimize this risk, an alternative is needed. This is addressed in a new report by West scientists: Alternative for SARS-CoV-2 Vaccine Primary Package Systems: Daikyo Crystal Zenith® Cyclic Olefin Polymer Vials. These vials have excellent performance features:
In short, Daikyo Crystal Zenith vials potentially are an excellent alternative to glass vials. With West data and support, provided by the Integrated Solutions program, an assessment can be made to determine if a package system based on these vials can meet the requirements of any of the various vaccine platforms under consideration. For more, contact an account manager or Technical Customer Service (TCS) representative.
Download the new 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.
Crystal Zenith® is a registered trademark of Daikyo Seiko, Ltd.
Daikyo Crystal Zenith® technology is licensed from Daikyo Seiko, Ltd.
<p><em>Lloyd Waxman, Harold Murray and Vinod Vilivalam</em></p><div id="g_93cd4f5a_be87_417c_be5f_5391eae75b241"><div><div><em></em> </div><div><strong>ABSTRACT</strong></div><div><strong> </strong></div><div><strong>Purpose: </strong>The shipment and storage of biopharmaceuticals in prefilled syringes (PFS) places new demands on PFS performance. Studies compared package integrity of glass and plastic PFS: piston movement was evaluated under reduced pressures to simulate transport by air in non-pressurized holds, and container closure integrity was tested on PFS that had been frozen or frozen and thawed, since some biopharmaceuticals are stored and transported in the frozen state. Piston release and travel forces were also measured in plastic PFS since in order to be competitive with siliconized glass PFS, the functional characteristics of plastic PFS must meet or exceed the criteria established for glass PFS.</div></div></div>
In 2018, we saw a record-setting year for new-molecular entity (NME) approvals (59) at the FDA1 versus 46 in 2017. 58% were for orphan drugs (patient population less than 200,000 in the US) with 17 biologic-based NME’s. Biosimilars are gaining traction in Europe, in particular. Major factors that are driving the market growth are next-generation business, high growth in chronic diseases, less expensive biosimilar drugs and favorable government regulations.
Thanks to the hard work of the West without Borders’ committee this year, the Kearney, Neb., team members had an exceptional campaign. This year, team members chose the Family Advocacy Network (FAN) as the local campaign recipient.
In today’s manufacturing processes, defects such as loose and embedded foreign matter may cause end of line rejects of drug products—potentially leading to a loss of product or even market recalls. At the same time, regulatory authorities are becoming increasingly more stringent and continually lowering acceptable levels of particulate matter.
Our team in Waterford, Ireland recently welcomed its newest “team member.” In partnership with BUMBLEance, the team is excited to launch the new children’s regional ambulance service, BUMBLEance #15, which will operate and service children from the Southeast Region of Ireland. The new vehicle will be permanently based in Waterford’s car park.
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