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To continue to learn and innovate is truly a daunting task. The journey to success has many ups and downs, but the end of that journey is not necessarily about knowing what worked or did not, but what to do with those learnings. In West’s journey to becoming a world leader in integrated containment and delivery (i.e., our learning experience), we continue to focus on market needs and listen to the voice of the customer. There are few better places to engage with customers and learn about the state of an industry than a trade show or conference. Below are some learnings (Part 1) – first-hand accounts of changes and trends that are shaping the pharmaceutical landscape that have been the topic of conversation at recent shows. Stay tuned for Parts 2 and 3.
Biologic drug formulations are becoming the focus of many treatments -- from immunotherapeutics to cell and gene therapies. This segment’s dynamics continue to evolve at a pace where new formulations are being discovered rapidly, and in some instances, traditional packaging solutions are becoming increasingly incompatible. For example, a cure for a rare disease may lack the right containment solution. Certainly, this demands a new solution be brought to the market in order to treat patients in need.
These new drugs differ from their traditional small-molecule counterparts in that unfavorable interactions with primary packaging components are much more of a concern. For example, a glass vial can delaminate, leading to unwanted glass flakes in a drug formulation. Furthermore, contamination of syringes with heavy metals, i.e., tungsten, can result in complexation with drug formulation and subsequent deactivation.
At West, we offer a solution that can accommodate these concerns: Daikyo Crystal Zenith® cyclic olefin polymer containment and delivery systems – a high-performance alternative to glass. It is an integrated life-cycle solution that is designed to protect drug safety, purity and efficacy – from development through delivery. Keeping up with the market trend of biologics, West can provide the biopharmaceutical industry with a solution to administer lifesaving medications safely and effectively.
For more in-depth discussion on Daikyo Crystal Zenith and other West solutions for your biologic drug product, please contact a Technical Customer Support representative.
Daikyo Crystal Zenith® is a registered trademark of Daikyo Seiko, Ltd. Crystal Zenith technology is licensed from Daikyo Seiko, Ltd.
<p>Tibor Hlobik, Director, Prefillable Solutions and Technologies<br />Mike Gills, Customer Technical Support Process Engineer</p><p>Growth in biopharmaceutical therapeutics is leading innovation with prefillable syringe systems. These complex sensitive drug products require highly inert primary packaging materials for improved stability and delivery in perfect quality for reduced safety risk. This <span style="text-decoration: underline; color: #0000ff;"><a href="https://www.westpharma.com/west-login">poster</a></span> will provide a quality comparison of primary prefillable syringe options including glass, coatings/laminates and cyclic olefin polymers, and highlight the findings of a case study comparing 1mL long syringe attributes.</p>
In determining extractables from parenteral drug packaging systems, the FDA is clearly looking for appropriate choices of solvents, times, temperatures and other conditions that could impact the results of studies. The outcome of the studies should support the intended purpose – to allow for practical correlations and design of leachables studies.
The challenge of assuring integrity of a sterile package is more complicated than many realize. As such, drug formulators in pharmaceutical and biotechnology companies often times underestimate the potential impact of the primary packages they select. A critical aspect to understand is container closure integrity (CCI) and leakage (i.e., failure of CCI or package integrity), is a major quality issue for sterile injectable products, as shown below.
Fran DeGrazio, Vice President, Global R&D, TCS and SPM, Pharmaceutical Packaging Systems, recently contributed a chapter on primary container components to <em>Quality by Design for Biopharmaceutical Drug Product Development</em>. The volume, which was released in April 2015, is the first comprehensive overview of QbD as it applies to nearly every aspect of biopharmaceutical development.
Daikyo Crystal Zenith® (CZ) Pre-Fillable Syringe (PFS) systems were designed to maintain purity, integrity, and efficacy of premium biopharmaceutical therapies. The system minimizes the potential contamination issues associated with glass and helps to reduce the risk of product interactions, delays in development and scale up, and possible recalls. As an extension of the existing 1mL Long Insert Needle Barrel Assembly, West and Daikyo are proud to introduce the new 2.25mL Insert Needle (IN), providing drug manufacturers a larger volume option for the next generation of autoinjectors for at-home therapies.
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