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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.
A way to mitigate this concern is with elastomer stoppers with FluroTec® barrier film. The FluroTec film, which is based on the co-polymer poly(ethylene tetrafluoroethylene), is laminated onto the elastomer stopper. It serves as an effective barrier between the drug product and elastomer, reducing the risk of leachables and volatile organic compounds from contacting the drug product. This has been demonstrated experimentally and was discussed in detail in a recent white paper by West scientists, Elastomer Stoppers with FluroTec® Film: The Right Choice for SARS-CoV-2 Vaccines, which considers the importance of FluroTec barrier films for SARS-CoV-2 vaccines.
For more information on West products and services, 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.
Part 1 of this two part blog series, gave a high-level overview of the new ICH guideline <em>Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management</em>. In part 2 of this blog series, some of the key takeaways will be discussed in more detail. <em>Q12</em> is intended to help companies demonstrate increased product and process knowledge, and understand which post-approval changes will require a regulatory submission, as well as the level of reporting for each category.
Fill-Finish engineering and process development are a critical step to ensuring product quality and manufacturability for injectable products. Fill-Finish involves technique driven process steps with considerations around patient safety at the forefront of each step. The complexity of aseptic processing and sterile fill-finish operations will continue to grow as more complex drug products enter the pipeline.
Marisa Leuzzi, Senior Specialist, Global Communications, from our Exton Headquarters, is one of the growing number of coronavirus survivors. Her experiences with her illness is not uncommon – but what she did after her recovery to keep her family whole is remarkable.
<br />In 2016, the China Federal Drug Administration (CFDA) made two announcements regarding packaging of parenteral drug products. Per these announcements, stability studies of packaging materials should refer to protection, compatibility, safety and functionality properties.
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.
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