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There is no doubt biologics and biosimilars will remain one of the hot topics in 2021. This is due to the pandemic period of SARS-CoV-2 and the innovative treatments and vaccines that are under development at accelerated speed. Several questions can arise regarding selection of the proper primary package system for a biologic/biosimilar.
Some common questions that arise frequently are:
These questions are especially challenging for a company that may have expertise in drug development, but not primary package systems.West can help. Based on extensive knowledge and a history of market leadership, West offers primary packaging systems that can address these and other questions. An example is the Ready Pack™ system, which comprises NovaPure® stoppers, Flip-Off® CCS (clean, certified, sterilized) seals, and Schott adaptiQ® glass vials. In particular, NovaPure stoppers have a FluroTec™ barrier film in areas that contact drug product. This film, based on poly(ethylene tetrafluroethylene), provides added protection by reducing:
Each NovaPure stopper is vision inspected using the Envision™ verification process to ensure low and controlled particle levels. Ready Pack system components are offered in quantities that support every development stage – from concept through commercialization. They may be a very good choice for biologics and biosimilars. For more information, contact an Account Manager or Technical Customer Service representative.
Ready Pack™, NovaPure®, Flip-Off®, FluroTec™ and Envision™ are trademarks and registered trademarks of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
adaptiQ® is a registered trademark of Schott AG.
West’s Ready Pack™ system with adaptiQ<sup>®</sup> products, that are part of the SCHOTT iQ<sup>®</sup> platform, enables both small and large customers the convenience and flexibility to purchase small quantities of sterile, high-quality, ready-to-use (RTU) components. Ready Pack system components are packaged separately but tested for use as an integrated system. Designed to support customers throughout small-scale R&D, clinical trials, fill-finish evaluation, and commercial-scale manufacturing, the Ready Pack system is a comprehensive, scalable packaging solution that helps customers get to market faster by making the same high-quality packaging available from start to finish. Ready Pack systems keep up with emerging ISO standards and our Ready Pack offering includes the latest glass packaging formats such as adaptiQ<sup>®</sup> clip nest, cup nest, and tray solution.
<strong>NovaPure® Components Overview</strong><br /><em>By leveraging nearly 100 years of pharmaceutical packaging knowledge and implementing Quality by Design principles, West has developed the continuously improving NovaPure® elastomer portfolio which can be ideal for all drug product phases.</em>
As drug development continues to evolve, further advances in delivery technologies will help to refine the overall drug delivery system, from improvements to safety and performance of delivery devices, to primary containers with consistent and higher-quality components.<br />
Small things sometimes come in large packages. When it comes to pharmaceutical components, small items like stoppers and plungers are often sold in quantities large enough to supply drug products to the world. But sometimes, and in particular during the early stages of drug development, large quantities are just too much of a good thing.
Cell therapies show tremendous promise for the treatment of a variety of life-threatening diseases. Their approvals are increasing. Because cell therapies are extraordinarily expensive, it is imperative that the primary packaging system maintain integrity through the shelf life.
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