Analytical Services

West is pleased to announce that its Online Store now offers the ability to request some of West’s elastomeric testing services! In addition to some of West’s highest quality products available ready-to-use in convenient small packs, USP/EP Combined Chemical and Functional testing on elastomers is now available for purchase on the Online Store. Additionally, shoppers who complete a purchase online are granted automatic customer-level access to the newly redesigned West Knowledge Center, offering in-depth technical content and support.

In 2011, the US FDA issued an advisory regarding the potential formation of glass lamellae in vials containing injectable drugs. This was in response to several drug recalls in 2010-11. The number of glass-related drug recalls has since declined greatly. This no doubt is due to key actions taken by pharmaceutical manufacturers before the drug goes to market, even during the development phases.

With the advancement of high-value biologic, gene, and cell therapy drugs, there is a growing interest in assessment of container closure systems (CCS) at the low temperatures experienced during processing, storage, and shipment. A vial-based CCS is usually capped at room temperature, but thereafter it may be exposed to low temperature conditions (0^oC to -180^oC), depending on both the drug characteristics and the expected duration of storage.

The recent Pharmapack meeting in Paris provided a great global overview of the latest in pharmaceutical packaging and delivery. This meeting involved not only the traditional tradeshow, but presentations from pharmaceutical and biotechnology companies as well as from companies offering packaging and delivery systems.

Combination products open up new vistas when it comes to delivering innovative therapies to patients in need, but teams bringing these products to the market face a number of significant hurdles. Recent surveys conducted by West at workshops held in PA and AZ revealed some of our customers’ biggest challenges. This is the final of our three blogs focused on these challenges — and how West can help Simplify the Journey™ when it comes to developing a combination product.

Extractables and leachables (E&L) remain as one of the hottest topics in China – a topic to which West makes a strong commitment – in order to anticipate and address ever-changing regulatory and technical requirements. As part of this commitment, Lynn Yao, Scientific Affairs Manager at West, presented Challenges of E&L Study Under Changing Regulatory Environment at the second-annual Extractables and Leachables China, hosted by Smithers Rapra, September 2019 in Shanghai. This event assembled local stakeholders and experts for two days of presentations, training, and discussion on the China regulatory landscape, testing methods, and technical advances.