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Selecting the right package for a drug product is essential. To do this, it is necessary to understand the surface chemistry of the components of the package to determine if any unwanted interaction with the drug product is likely.
For biologic drug products this is especially critical – issues that can result are:
Drs. Liang Fang and Lloyd Waxman have described a systematic series of methods to understand surface chemistry and interactions in a recent report. The approach is two-fold. The first aspect comprises complementary use of six surface methods (infrared spectroscopy, plasma emission spectroscopy, x-ray photoelectron spectroscopy, scanning electron microscopy, atomic force microscopy, and secondary ion mass spectrometry) to precisely define composition of a component surface. The second aspect comprises methods to examine for generation of protein-based particles resultant from interaction with a component surface. From this series of methods, a very clear picture can be developed of the suitability of a component for a drug product. In particular, this report shows major differences between two elastomer components that are represented as having barrier properties resultant from lamination or applied surface coatings.
West is committed to the safe and efficient delivery of drug products to patients. This commitment is reflected in the new Integrated Solutions program. West can partner with customers, and employ its experience, expertise, and facilities to help to select the right component for a drug product. For more, contact an Account Manager or Technical Customer Support (TCS) representative.
Christa Jansen-Otten and Dr. Heike Kofler will moderate the ”Prefillable Glass Syringe and the Appropriate Pharmaceutical Rubber Components: Processing, Packaging, Innovations,” at the 53° SIMPOSIO AFI in Rimini, Italy, on June 12-14, 2013.
On March 12, 2016, West sponsored the Girls Exploring Tomorrow’s Technology (GETT) Event at West Chester East High School in Pennsylvania.
Biosimilar development and approvals have been accelerated over the last several years. The rapid uptake in this category is due in large part to clarity on regulatory pathways that demonstrate interchangeability with the reference product and key patent expiry over the next decade. By 2025 injectable biosimilars are projected to comprise almost 50% of the accessible biologics market<sup>1</sup>. West recently conducted a survey of biosimilar companies to better understand their top needs for packaging and support services during drug development.
West’s Mike Schaefers and Heike Kofler recently published a chapter entitled, “Primary Packaging Components Elastomeric Closures for Pharmaceutical Applications” to APV Basics <em>Pharmazeutische Packmittel</em> (Elastomeric Pharmaceutical Packaging).
Our commitment to philanthropy has been embedded in West’s culture for more than 95 years, and is an integral part of our overall Corporate Responsibility Program. In particular, 2019 was a banner year for philanthropy at West. Our team members closed out the decade with considerable personal investments in both time and resources dedicated to improving their local communities and promoting a healthier world. Our Culture of Giving is a key aspect of the team member experience at all of West’s global sites.
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