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Scientific Insight Enables Risk Mitigation: Why West is By our Customers’ Side
As regulations increase across the pharmaceutical industry, reliable scientific evidence is needed to support the decisions being made during the drug development process in order to achieve the safe delivery of medicines to patients.
Recent regulations around issues such as particulate and heavy metals, require a strong understanding of the testing and analysis to move drug products to the market.
Collaboration with strategic suppliers is critical to managing issues associated with bringing a sensitive drug molecule to market. By supporting our customers from molecule to market, West works to build a close partnership that can provide the scientific analysis, data and regulatory support needed to mitigate risk, speed drug development, and get drug products to market to support patient health.
No matter what challenges our customers face during the drug product life-cycle, chances are West has faced them before. With nearly a century of industry leading experience, West may already have the answers you need, and if not, we can develop a scientific approach to find what you’re looking for. Working together, we can address issues quickly and effectively, helping to mitigate risks as early as possible in the development process by helping customers navigate regulatory and technical challenges.
To learn more about how West can help, check out our video here on our Integrated Solutions Program page.#WestByYourSide
Known for a commitment to excellence in elastomeric components, West has complemented its vial closure portfolio with the Flip-Off® seal brand. Particularly in its ability to provide solutions for aseptic and clean crimping, the Flip-Off seal demonstrates potential to become an industry standard.
Commitment to the safest and most efficient delivery of drug products requires a detailed understanding of the constantly changing regulatory landscape. Recently West presented a webinar series discussing the current regulatory requirements for packaging/delivery components and systems, to support not only customers, but the industry as a whole. Each averaged more than 300 registrants – clearly showing the interest in these areas.
Competition is increasing in the biopharmaceutical pipeline due to a growing number of new entrants, more players are bringing their drug all the way to market and many companies are utilizing accelerated development pathways, making it an even faster race to market. If you are like many other newly formed biotech companies, you’re doing your best to manage many activities critical to your success with limited resources, all while trying to accelerate your path to market.
The U.S. Food and Drug Administration recently issued a draft guidance, <a href="http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM346181.pdf"><span style="text-decoration: underline;">“Glass Syringes for Delivering Drug and Biological Products: Technical Recommendations to Supplement International Organization for Standardization (ISO) Standard 11040-4 (Draft).” </span></a>The document relates to issues encountered with glass Luer lock syringes when connecting to Luer fittings, including needles, needle-free Luer connectors, adapters and transfer units.
In a product’s development lifecycle, the importance of packaging can sometimes be overlooked until a packaging specialist becomes involved and can elucidate whether the packaging design is suitable and meets the tests for form, fit and function. Some companies that may not understand or emphasize the critical elements of a good package in the design phase may find out too late that the package is unsuitable after sustaining one or more failures during validation testing.