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Many parenteral drug products, such as monoclonal antibodies, are susceptible to degradation over time. To enable a longer shelf life, such drugs are often stored in a lyophilized state. Lyophilization (freeze-drying) is a process by which water is removed from a drug product. In the absence of water, all metabolic processes stop, making lyophilized drug products far more stable.
In considering the container closure integrity (CCI) performance of a vial/stopper/seal system for a lyophilized drug product, a key element is resistance to exposure to water. It is often wrongly assumed that exposure to water occurs only as a result of residual water in the elastomer stopper. However, there are several possibilities, including:
To help reduce these possibilities, it is very important to consider the material properties of the vial, stopper and seal, and their treatment prior to use. For example, stoppers are often sterilized by autoclaving (steam at approximately 120°C), so it is necessary to ensure stoppers are properly dried before use to minimize risk of releasing residual water.
West offers vials, stoppers and seals well-suited for lyophilized drug products, including:
For more on how West supports lyophilized drug products, visit our website or contact a Technical Customer Service (TCS) representative in your region.
PLASCAP® and Daikyo Crystal Zenith® are registered trademarks of Daikyo Seiko, Ltd.
LyoSeal® is a registered trademark of West Pharmaceutical Services Deutschland, GmBH, a subsidiary of West Pharmaceutical Services, Inc.
West’s Kinston, NC facility was recently recognized with an Honorable Mention at the 2016 International Society for Pharmaceutical Engineering’s (ISPE) Facility of the Year Awards’ ceremony on June 7, 2016, in Bethesda, Maryland. The award acknowledged the West team’s creativity and innovation during the Ready-to-Sterilize (RS) Expansion project, which was completed in June 2015.
West is proud to announce that its 2017 Corporate Responsibility Report has been published and is now live on the West website. In its second year, this report provides a summary of West’s efforts in six key areas including Compliance and Ethics, Philanthropy, Diversity, Health and Safety, Environmental Sustainability and Quality. Being a good corporate citizen is part of West’s DNA. This is evident in our rich history of caring for the communities and environments in which we work and live. The 2017 Corporate Responsibility Report is a testament to this commitment, and we are seeing great progress across all of our focus areas.
The combination product market has seen a significant amount of growth,<sup>i</sup> driven primarily by the rise in chronic disease indications, the demands for self-administered therapies and technological advancements. The use of combination products simplifies the process of drug administration for the patient and/or the caregiver and, in some cases, allows the patient to receive treatment at home rather than having to travel to a medical facility. However, there are many challenges that need to be navigated as one considers the transition from a vial system to a needle-based combination product.
<p>There have been many innovations over the past century since it was first shown that insulin injections could help control chronic diabetes. Advances in hardware and software have resulted in more accurate blood glucose sensors that work via less invasive means and insulin pumps that have become smaller and ever more sophisticated. As we discussed in our <a href="/blog/2017/july/growth-in-glp-1-drugs-may-offer-improved-outcomes-to-people-with-type-ii-diabetes">last blog</a> [1], there are also newer drugs, that when combined with traditional insulin therapy, can help patients better control the blood glucose levels.</p>
Why is meeting customer needs no longer enough? In an expanding global economy with international competition, meeting customer needs is simply not enough. Meeting customer needs leads to customer satisfaction but does not lead to customer loyalty, which is what keeps companies in business.
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