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
West presented a webinar: Navigating Particle Challenges in Sterile Drugs from Component to Patient by Fran DeGrazio, Vice-President, Scientific Affairs & Technical Services, and John Rech, Technology Manager – Particles, Analytical Lab Services, LLC.
Key insights were obtained through survey responses from the over 300 registrants – in particular, dispelling the general perception that particle formation resultant from drug/package incompatibility or contamination is infrequent. Over half of respondents report incompatibility as an issue – a reason why packaging components must be screened early in the drug development cycle. Moreover, there appears to be no standardization on testing parameters, or use of statistical methodology for interpretation of results.
Particulate is a thrust area for West Analytical Services, LLC. Extensive experience indicates that particle levels vary based upon:
Further, this experience indicates that rigorous statistical methods are required for meaningful interpretation. To view the full recording of the webinar please click here. For more on how West can assist in addressing particle issues, contact an Account Manager or Technical Customer Support (TCS) representative.
West is proud to announce that we have published our 2021 Corporate Responsibility (CR) Report, Purpose. Driven., which is now available on <a href="/about-west/corporate-responsibility">West’s website.</a> <br />This is West’s 6<sup>th</sup> annual CR Report, and highlights ESG successes from over the past year, including progress on environmental sustainability goals, diversity and inclusion, and success around the Company’s philanthropic efforts. The publication also highlights some of the recognition received for our ESG (Environmental, Social, Governance) performance, including placement in Barron’s Top 100 Most Sustainable Companies, Corporate Social Responsibility Programme of the Year from Pharma Industry Awards in Ireland, and a Silver Stevie Award for Corporate Social Responsibility.
We are delighted to share that West has been honored at the Korea Bioprocessing Excellence Awards (KBEA) for the second year in a row. This year, we were recognized as the grand winner of the Best Bioprocessing Supplier Award: Fill-Finish.
For injectable drug products, coring and fragmentation of elastomer stoppers is a critical concern. This is caused by tearing or shearing a fragment of the stopper in a vial during insertion of a needle or a spike. The cores/fragments that enter the drug product may lead to harmful patient outcomes. Testing of stoppers is a must for many pharmacopeias. Coring and fragmentation is complex and influenced by many factors, in particular the stopper and the needle.
Development of vaccines for COVID-19 and its variants continues to present challenges such as accelerated timelines. Since there is not the usual time available for selection, evaluation, and qualification of the package and delivery systems, risks must be mitigated at every phase. For vaccines packaged in prefilled syringes, use of an elastomer plunger laminated with FluroTec<sup>®</sup> film can help.
Drug developers must understand and mitigate the risk of various chemical entities (leachables) migrating from any material that comes into contact with their drug product. Failure to execute an appropriate extractables and leachables assessment could lead to failures in meeting agency expectations and a delay in drug development timelines.
English
Chinese
