Quality

At West, we are committed to safeguarding the health and safety of the millions of patients who use our products every day. This commitment is anchored in our Core Value of Leadership in Quality, which ensures we never compromise on quality because we know that patients are counting on us.

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.

Biologic drugs, rather than being synthesized from other compounds, are generally made using human or animal proteins. At the molecular level, they’re usually larger and much more complex than regular drugs. Routine oral administration of biologics has not been mastered as there is enzymatic and pH-dependent degradation of drugs in the stomach and intestines. Low permeability of epithelial cells that line the gastrointestinal tract means that proteins and peptides typically have extremely low bioavailability in the range of around 0-2% when taken by mouth.

On March 26, the Delaware Valley Chapter of PDA and West Pharmaceutical Services, Inc. co-sponsored a workshop: Defining a Strategy for Combination Products, at West’s headquarters in Exton, PA. More than 150 people from 45 companies that provide drug products and combination products attended. In prior PDA events, combination product regulatory challenges have been cited often as an area both of interest and confusion. This workshop aimed to address them.

Focused on meeting customer needs in different markets and regions, West offer two types of washed Ready-to-Sterilize (RS) rubber closures: Regional-Washed RS and Westar^® RS.

Cell therapies offer a powerful new approach to treat cancer and other serious conditions. The manufacture and supply of these therapies is complex – to address the short shelf lives of such living products, storage and shipping is done at cryogenic temperatures (liquid nitrogen, approximately -180^oC). A challenge is selecting the right container system.