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Lyophilization removes water from a drug product through three phases: freezing, primary drying or sublimation, and secondary drying or desorption. To begin the process, the drug product is frozen and then placed under a vacuum, which allows the ice to change from solid to vapor without passing through a liquid phase.
The process typically includes the following phases:
According to the FDA, lyophilization has many advantages, including enhanced stability, extended shelf-life while maintaining potency, increased resistance to changes in temperature, and rapid and easy dissolution of the reconstituted drug product. However, the process requires increased handling and processing time, and can be complex and costly – particularly if the materials selected for the primary container are not consistent or interfere with the lyophilization process. The proper selection of a lyophilization stopper manufactured with Quality by Design (QbD) principles can help to ensure that the freeze-drying process moves smoothly while preventing and/or reducing potential contamination from the atmosphere or the container closure system.
With the explosive growth in social media, mobile devices, cloud computing and access to data both internal and external to West (now referred to as Big Data), West IT has been working to ensure that we are able to leverage these transformational trends. In 2012, we updated our IT strategy to allow us to be part of the revolution while making it feel more like an evolution. The initial phase began with investments in cloud technologies – both private and public – to drive down IT operating costs and to enable us to take advantage of software enhancements made by our strategic partners.
Combination products open up new vistas when it comes to delivering innovative therapies to patients in need, but teams bringing these products to the market face a number of significant hurdles. Recent surveys conducted by West at workshops held in PA and AZ revealed some of our customers’ biggest challenges. This is the final of our three blogs focused on these challenges — and how West can help Simplify the Journey™ when it comes to developing a combination product.
In March technical experts from both West and SCHOTT joined together to share insight on the current trends and challenges of the injectable drug market. The two companies held technical seminars sharing their knowledge and expertise related to component and container selection, as well as the integration of primary packaging for filling from clinical to scale up. <br />
This April, West is proud to celebrate Diversity Month. West has a long-standing commitment to diversity, equity and inclusion, which is inherent in our core value of One West Team. In the wake of recent events, West is deepening our commitment and becoming a stronger advocate.
In 2012, West rolled out a new global branding initiative that included a new tagline: By Your Side for a Healthier World<sup>TM</sup>. What does that mean? Every day, injectable drugs and vaccines are administered to improve the health of millions of patients around the world. And every day, West works by the side of its health care partners to design and manufacture drug packaging and delivery systems that will bring those drugs and vaccines from concept to the patient more efficiently, reliably and safely. This has been West’s legacy since the Company was founded in 1923.
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