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West is committed to partnering with and providing analytical and technical support for customers so that they can successfully develop drug products and deliver them to patients.
To support this commitment, West Analytical Services, LLC has decades of experience and expertise in four areas that are critical to the performance of packaging components and delivery systems, as well as the compatibility and fit with the drug product. These areas comprise not only having staff with the right technical expertise and expert-level knowledge of all industry regulations, but also state-of-the art facilities, examples of which are:
*Full details and more at website
Knowing the ever-changing regulatory landscape, and having the expertise and facilities, West Analytical Lab is uniquely positioned to partner with customers to design, execute and interpret studies needed to help their drug products move most efficiently and safely to patients. The right study, performed the right way, gives not just data, but answers.
Visit the relaunched West Analytical Services section on westpharma.com to see more on this, and see case studies about how West has helped customers achieve success.
West Analytical Services, LLC continues to invest in the expertise and technology needed to support and partner with customers. This is essential to enable customers to pair new and more complex drug products with the right containment systems, delivery systems and combination products – and navigate the challenging, and ever-changing, regulatory environments. Expansion of the capabilities is focused in four critical areas: (1) extractables and leachables (E&L); (2) container closure integrity (CCI); (3) particle analysis; and (4) testing for packaging, devices and combination products.
In 2012, West rolled out a new global branding initiative that included a new tagline: By Your Side for a Healthier World<sup>TM</sup>. What does that mean? Every day, injectable drugs and vaccines are administered to improve the health of millions of patients around the world. And every day, West works by the side of its health care partners to design and manufacture drug packaging and delivery systems that will bring those drugs and vaccines from concept to the patient more efficiently, reliably and safely. This has been West’s legacy since the Company was founded in 1923.
<p style="margin: 0in 0in 0pt;"><span>Every day, all day, safety matters. Safety never takes a day off. All around us we see safety warnings such as allergens on food labels, use-by-dates on milk and expiration dates on medications. There is no substitute for doing things safely. For pharmaceutical and biotechnology companies offering parenteral drug products, patient safety is the utmost concern.</span></p>
Ensuring the safe containment of sensitive drug formulations requires a thorough evaluation of the container closure system. Selecting the packaging components requires knowledge about not only the drug formulation's requirements, but also the components’ material properties. Chemical compatibility of components with the drug formulation is key. Proper selection of components will provide the right closure design, assist with handling and help ensure container closure integrity throughout a drug product’s shelf life. Managing these factors well is critical, and West can help.
Knowledge generation and risk reduction are goals of combination product testing. A risk-based, and standards-based, testing strategy creates not only a quality product, but ensures continuity between past and future data sets. This enables the long-term, safe and efficient delivery of drug products to patients. And time to market is improved by reducing product launch false starts.<br />
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