Previous Blogs

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By Steve LoCastro

April 16, 2014

A new regulatory guidance in the US has clarified expectations for pharmaceutical companies wishing to transition from an existing pharmaceutical component wash process to another, such as the Westar® Ready-to-Sterilize (RS) process.

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By Tibor Hlobik

March 05, 2014

Many of the top-selling biologic drug products will soon come off-patent. As a result, according to IMS, the biosimilar market is expected to reach between US$1.9-2.6 billion by 2015.

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By West Technical Operations

February 20, 2014

While all major regulatory agencies have expectations regarding the ability of a pharmaceutical wash process to provide a suitable level of pre-sterilization depyrogenation, the United States (U.S.) Food and Drug Administration’s (FDA) requirements appear to be particularly stringent.