We apologize your item could not be found. Not all items are listed on our website. Please contact your account manager for details regarding your searched item.
Material number (eg: xxxxxxxxxxx) no space or hyphen needed.
No Results Found
To ensure drug product efficacy, components of primary packaging and delivery systems must be evaluated for safety and performance. An essential aspect of this is an extractables and leachables (E&L) study. The purpose of an E&L study is to identify compounds (organic and inorganic) that may migrate from components into drug product formulations, in particular those that may put patient safety at risk.
The first phase is the extractables evaluation. This employs aggressive conditions to extract and ultimately identify any compound that possibly could appear in the drug product formulation. Components are refluxed in a selected liquid media at elevated temperature for a fixed time. Resultant media typically is analyzed via chromatography and mass spectrometry, for both presence and identity of compounds. Accuracy of standard mass spectrometry techniques often is not sufficient though.
Some compounds are difficult to identify by a molecular weight value reported by unit resolution mass spectrometers. To address this issue and most accurately identify extracted compounds, West Analytical Laboratory Services has acquired quadrupole time of flight (QTOF) mass spectrometry instrumentation. Providing molecular weight values to four decimal places, QTOF instrumentation enables increased accuracy in identifying extracted compounds. This information is crucial; knowing identities enables evaluation of potential toxicity, and concomitant determination of whether said compounds should be targets of the subsequent leachables study.
Many properties of packaging components/systems and delivery devices can be measured by multiple methods. The key is to select the right methods. West’s Analytical Lab Services is well equipped for this, having the staff, expertise, and facilities needed. For more, contact an Account Manager or Technical Customer Support (TCS) representative.
The drive for high-quality packaging has helped manufacturers focus on increasing consistency of performance in devices such as auto-injector and patch injection systems. In addition, there is an increased focus on providing drug delivery systems that are easy to use. A consistent quality of components can help to improve performance and ensure delivery in the home environment, while user-centric systems can help assist with compliance.
<p><em>A scientific poster by: Clara Goodfield, Eugene Polini, Amy Miller and Wayne Curry</em></p><p><em>The ideal sterilization process destroys all microorganisms rapidly with minimal adverse impact on the chemical and physical properties of the elastomeric closure. Developing and validating an acceptable sterilization process is critical to the drug product quality. This study served to help understand the potential deterioration of physical and chemical properties, the possible impact to functionality and the potential changes to the extractable/leachable profile as a result of sterilization</em></p>
I am the Head of Procurement for Civica, one of West’s customers. <br />Civica is working to solve two big problems in U.S. healthcare - drug shortages and predatory pricing. Our mission is to ensure quality generic and biosimilar medications are available and affordable to everyone.
West is pleased to announce the availability of a new sterile drug vial seal, the Flip-Off<sup>®</sup> Plus<sup>RU</sup> seal. Part of West’s Flip-Off® seal product family, these new ready-to-use seals help pharmaceutical and biopharmaceutical manufacturers protect the safety and integrity of their drug products while meeting regulatory requirements for increased drug cleanliness and safety.
As scientists continue to gain a better understanding of the Corona virus, we are witness to a growing number of novel and repurposed therapeutics in development along with clinical trials designed to attack multiple aspects of the unique clinical pathologies. On the vaccine side, manufacturers are trying a multi-pronged approach to stimulate the immune system by using both traditional approaches (i.e., protein subunits, inactivated viruses, and virus-like particles) and novel platforms that are based on delivery of mRNA, DNA, or non-replicating viral vectors that can trigger the body to make the viral proteins themselves. The typical timelines, not counting the time it takes to demonstrate safety and efficacy of these vaccines, can range from months to years and even up to a decade to successfully design, manufacture and consistently produce high quality vaccines.
English
Chinese
