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At West, our focus is on supporting the biopharmaceutical industry in qualification and commercialization of containment and delivery systems for injectable medicines. Selecting high-quality drug packaging that meets regulatory standards is essential to a drug manufacturer’s success. West’s top priority is delivering high-quality packaging products that meet the exacting quality standards and product specifications customers require.
West’s Global Technical Customer Support (TCS) Team is key to this effort – focusing on biopharmaceutical industry needs and partnering with customers throughout the process of selecting and qualifying primary packaging solutions and drug delivery systems. This includes a sound understanding of both the packaging requirements defined by the drug product and the regulatory standards. TCS also provides technical information and scientific data on West and Daikyo products, and facilitates interaction with other West services, e.g. West Analytical Services, to reduce drug product time to market.
Additionally, TCS is active in the biopharmaceutical industry, e.g., participation in industry groups, attending conferences and exhibitions, and delivering technical reports and presentations. This enables TCS to be constantly aware of the latest trends.
Broad technical knowledge, understanding of industry needs, and service excellence ensure that West TCS remains the scientific destination for customers.
Contact a Technical Customer Support representative today to see how West can support you bringing safe, effective drug products to the market.
In its 95+ year history, West has developed and marketed a very large number of elastomeric formulations, each designed to address particular market demands. Over this time, various aspects of drug product quality have gained attention – a fact reflected in the numerous regulatory guidances that have been issued. An early focus of these guidances was extractables and leachables, followed closely by particulate matter and container closure integrity. Beyond these regulatory requirements, the market demands product portfolios that enable platforming and predictable, consistent product quality and performance.
West’s Kinston, NC facility was recently recognized with an Honorable Mention at the 2016 International Society for Pharmaceutical Engineering’s (ISPE) Facility of the Year Awards’ ceremony on June 7, 2016, in Bethesda, Maryland. The award acknowledged the West team’s creativity and innovation during the Ready-to-Sterilize (RS) Expansion project, which was completed in June 2015.
The pharmaceutical industry’s focus on extractables and leachables from packaging/delivery systems began during the mid-1990’s. Today’s regulatory agencies are more educated about the process, and drug product formulations have become more complex, which makes the need for robust extractables and leachables programs more critical than ever. In fact, failure to properly evaluate extractables and leachables has had a negative impact on many pharmaceutical companies, e.g., late-stage stability failures, submission delays, and recalls. To avoid this, the first question to ask is – “where do I start?”
The definitions of <em>personalized medicine</em> vary. However, all of them indicate that the once popular therapy approach of “<em>one drug fits all</em>” is outdated. The Council of the European Union defines personalized medicine as <em>“[p]roviding the right treatment to the right patient, at the right dose at the right time.”</em><sup>[1]</sup>.
The regulatory landscape in China continues to evolve and become more stringent. In December 2018, the Chinese Pharmacopoeia Commission (ChPC) published: Second Draft for Comments on Guideline for Stability Study of Plastic and Rubber Pharmaceutical Packaging Materials. This guideline comprises part of the results of a research project organized by ChPC in 2016 and is one of the actions taken by National Drug Administration of China (formerly the China Food and Drug Administration, CFDA) to support the previously announced Opinions on Reforming the Review and Approval System for Drugs and Medical Devices (No. 44).
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