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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.
To support customers as they navigate the path from drug product discovery to commercialization, West has undertaken a new, proactive strategy: <em>Integrated Solutions.</em> For almost 100 years, West has been developing technical and regulatory expertise in primary drug packaging, delivery devices, and combination products. That wealth of industry experience is now offered to customers who can employ it for any stage of development (Prescreen and Compatibility, Clinical Phases I / II / III, and Lifecycle Management).
Particles in drug products can come from many sources—extrinsic (from outside the process), intrinsic (from within the process) and even inherent (as part of the drug formulation)<sup>1</sup>.
Fluoropolymer-laminated elastomer stoppers and plungers provide enhanced performance for container and delivery systems for parenteral drug products – especially sensitive biologic drug products. Among the many fluoropolymers available, West uses ETFE [poly(ethylenetetrafluoroethylene)] for its FluroTec<sup>®</sup>–laminated products. Selection of ETFE was based upon ease of moldability and the following factors.
Particles in parenteral drug products have been a major source of product recalls in recent years (>100 from 2010-16). They are especially problematic for biologic drug products, where they can induce formation of protein particulates that may have immunogenic effects.
A parenteral drug product contaminated by particles is a potential health threat. In the bloodstream, particles can cause serious issues, such as capillary occlusion and immunogenic responses. In most cases, the observation of particles in a drug product leads to a recall.
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