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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
Component processing is a source of risk and variability, especially for loose particulate and silicone oil that can compromise quality, putting patients at risk. To simplify drug development and streamline manufacturing, pharmaceutical companies can select cartridge plungers and lined seals in a ready-to-use format.
Protein-based therapeutics are examples of the advancement of modern medicine and a revolution in drug discovery. Monoclonal antibodies (mAbs) account for the majority of biologic FDA approvals, and due to their low bioavailability by oral delivery means, they necessitate a shift to parenteral delivery. Hence, mAbs are typically packaged and stored in liquid or lyophilized format in glass vials, prefilled syringes, or cartridges for later injection.<br />
Members of the West Pharmaceutical Services, Inc. (West) Marketing Unit had the pleasure of attending the recent FDA Public Meeting on Tuesday, May 21, 2019 regarding 503B Compounding Pharmacies and the cGMP draft guidance, as well as office stock issues which had generated many comments.
To continue to learn and innovate is truly a daunting task. The journey to success has many ups and downs, but the end of that journey is not necessarily about knowing what worked or did not, but what to do with those learnings. In West’s journey to becoming a world leader in integrated containment and delivery (i.e., our learning experience), we continue to focus on market needs and listen to the voice of the customer. There are few better places to engage with customers and learn about the state of an industry than a trade show or conference. Below are some learnings (Part 1) – first-hand accounts of changes and trends that are shaping the pharmaceutical landscape that have been the topic of conversation at recent shows. Stay tuned for Parts 2 and 3.<p> </p>
West’s Tibor Hlobik will present a poster at the 2014 PDA Universe of PFS and Injection Devices Conference at the Hyatt Regency Huntington Beach Resort & Spa, Huntington Beach, California, on October 6-7, 2014. The poster presentation will take place on October 7, at 10:00 a.m.
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