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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
When choosing an elastomeric formulation for a stopper or plunger used to package parenteral drug products, there are several misconceptions related to the importance the elastomer class plays on the chemical and physical properties of the elastomer. Often we hear customers make general statements such as “chlorobutyl elastomers are better” or “bromobutyls have an advantage in property X.” In actuality, each elastomeric formulation is unique and has different properties that are independent of the class of elastomer.
Thanks to the hard work of the West without Borders’ committee this year, the Kearney, Neb., team members had an exceptional campaign. This year, team members chose the Family Advocacy Network (FAN) as the local campaign recipient.
Where science and technology are evolving quickly, a good networking structure is needed to keep pace of advancements. This is especially relevant for regulatory agencies in the pharmaceutical field. EMA recognizes this and addresses it with the strategic plan: Regulatory Science to 2025 – focused on quality, safety and efficacy of both human and veterinary medicines. The draft of this plan, which was created by the Member States and the European Commission, and comprised input from two workshops with stakeholders, was published in December 2018 for a six-month public consultation.
Bettine Boltres, Ph.D.
Principal, Scientific Affairs, Packaging & Delivery Systems
We recently sat down with Dr. Bettine Boltres, our contact for scientific affairs and technical solutions for glass. In her role she is supporting pharmaceutical companies to address glass-related topics from a scientific perspective and to gain a deeper understanding of the material that holds their valuable drug products. Having done this for many years, we wanted to know what the most frequently asked questions are that she encounters. Please read Part 1 of our two-part series around the 10 most commonly asked questions around glass vials:
West’s customers are very familiar with our Drug Master Files (DMFs) and Letters of Authorization. West maintains some of the most active DMFs held by the FDA and Health Canada, and we’ve provided customers with over 9,000 LOAs since 2008.