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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.
The glass transition temperature (T<sub>g</sub>) is the temperature at which a material loses its viscoelastic properties. It is also indicative of the lowest temperature at which the polymer system will retain its functionality.
The number of biologic drug products marketed with an injection device has approximately quadrupled over the last decade. The growth in these drug therapies has been driven by several factors including new, self-administered therapies for chronic conditions such as rheumatoid arthritis and autoimmune diseases. In addition, injectable therapy is now being considered as a treatment for more conditions, including asthma and cholesterol problems.
The coring and fragmentation of elastomer components used in containment of parenteral drug products continues to be a challenge. Many factors influence these phenomena, so it is critical that a pharmaceutical manufacturer understands how a vial system will be used, for example: what is the recommended needle gauge; is it single- or multi-dose; could spikes, vial adapters or closed system transfer devices be used. Cores and fragments can be generated by needle penetration of the elastomer components. Cores are formed by the needle cannula cutting the elastomer – ordinarily they are cylindrical. Fragments are formed via an abrasion phenomenon of the needle penetration – shapes are irregular. <br />
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.
The use of proteins as therapeutics has focused attention on the need to maintain the stability of these labile molecules during both storage and shipment. The trend in the pharmaceutical industry has been to package therapeutic proteins in prefillable syringes made of glass. However, some biologics are not stable in glass syringes due to sensitivity to adhesives used in their manufacture and to tungsten oxides generated during needle placement.