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The current pharmaceutical market has faced a variety of challenges, including increasing expectations for quality from end-users and regulatory agencies driven by concern for patient safety. While pharmaceutical companies are working to assure that new quality and compliance paradigms are met, a balance must be achieved between the reality of managing costs to provide a product that meets payer’s requirements and facilitating profitability in order to continue adequate business reinvestment.
To balance these priorities effectively, the adoption of Quality by Design (QbD) concepts is gathering momentum within the industry. A process designed with QbD principles requires a significant up-front investment. However, it delivers an improved, data-driven output providing manufacturers with superior product and process understanding that minimizes process risk, emphasizes patient-critical quality requirements and enhances drug product effectiveness. A more efficient and controlled process, results in a final deliverable that is a much higher-quality product with well understood and controlled sources of variation.
The Quality Target Product Profile (QTPP) forms the basis for drug product formulation and process development in a QbD concept. A series of considerations should be made for the QTPP of a sterile product. Some of these considerations include the desired product performance based on the intended clinical setting, dosage strength and delivery mode, pharmacokinetic characteristics, drug product quality criteria, sterility and the container closure system itself, just to mention a few.
Quite often, the container closure system is a final consideration in the drug development process. However, the primary package is critical to the success of drug stability and the effectiveness and compliance of a commercial manufacturing process. Realistically, the QbD framework can be adopted by pharmaceutical industry suppliers in order to provide benefits to the pharmaceutical drug manufacturer.
High-quality components and sterile packaging must be well-understood to provide significant benefit to the overall container closure or delivery system.
Watch for a new product from West based on the QbD concept – coming next week!
West is committed to the safe and efficient delivery of drug products to patients. An important aspect of this commitment is engagement in standards-setting organizations; West is a member of the European Pharmacopoeia Commission, Group of Experts 16 – who contributed to European Pharmacopoeia 9.5 (effective July 2018).<br /><div> </div>
At West, patient safety is the utmost concern. Intuitively, one might not think that Project Management can have an impact on patient safety – but it does – a very important impact. West Analytical Services LLC partners with customers to design and perform studies that help to enable the safest, and most efficient, delivery of drug products in West components/systems.<br />
The Exton West without Borders campaign came to a close with the annual picnic on Friday, June 3. This year the campaign benefitted the Leukemia & Lymphoma Society (LLS), one of the most respected organizations dedicated to finding a cure for blood cancers and providing important support services for those in our community affected by this disease.
China has now stepped into its “golden age” of biopharma; this year regulators approved the country’s first biosimilar product, HLX01. Developed by Shanghai Henlius Biotech, it will be used primarily for treatment of non-Hodgkin’s lymphoma<span>. Biologics are sensitive large molecules, so selecting the appropriate packaging and delivery system is critical. To this end, West Pharmaceutical Services, Inc. (“West”) recently held <em>China BioPharma Summit for Injectable Drug Packaging and Delivery Systems</em> in Suzhou. Over 200 persons attended.</span>
My grandfather started Wickert in 1901. He was a blacksmith who was involved in the production of horseshoes – the tires of their time! Living in an area with plenty of vineyards, the company went on to make wine presses before switching to rubber presses after WW2. <br />The invention of the rubber sole for shoes completely changed the company’s destiny. A lot more presses were needed to produce the soles – so production ramped up. This specialism eventually led Wickert on to creating presses for pharmaceutical rubbers. And that’s where our story and West’s come together.
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