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Pharmaceutical and healthcare companies around the world rely on the expertise of West's contract manufacturing team—formerly known as The Tech Group to create innovative, safe and effective drug delivery systems that bring important therapies to patients. For those companies – like ours – quality and innovation are of the utmost importance.
In part one of our video series West on the Road – Tempe, we look at how West's contract manufacturing Rockford campus in Tempe, Arizona is developing advanced automation systems and programs to ensure the quality and efficacy of drug delivery and monitoring systems. This begins by establishing manufacturing processes based on a deep understanding of the customer’s needs and the products themselves. West's contract manufacturing engineers at the 96,500-square-foot facility learn our customer’s products inside and out. They combine that insight with their deep knowledge of medical devices and materials, such as plastics, as well as the latest in insert and multi-shot molding techniques to ensure we’re meeting the needs of our pharmaceutical partners and the patients relying on them.
While the medical manufacturing industry today may be complex as ever, Director of Operations, Mike Moran, believes that manufacturing processes will only grow in complexity in the coming years as a changing healthcare environment—one that is ever more patient-centric—will continue to demand more of the pharmaceutical industry and their manufacturing partners.
Ultimately, people at the contract manufacturing plant understand the critical role that they play in bringing drug delivery systems from concept to patient and delivering the high quality that our pharmaceutical customers – and patients – demand.
Drug delivery via cartridge-based systems has been around for many years, with traditional applications being for the dental and insulin markets. These traditional markets will continue to maintain much of the volume for cartridge-based systems in the future; however, there is an increasing trend toward other therapeutic classes of drugs, such as those that treat auto-immune diseases, that never used cartridges before. This trend, along with the projected growth in the insulin market, indicates substantial overall growth in the cartridge space over the next several years. This Blog discusses the issues driving these trends and the West product portfolio in the cartridge market.
The regulatory landscape in China continues to evolve and become more stringent. In December 2018, the Chinese Pharmacopoeia Commission (ChPC) published: Second Draft for Comments on Guideline for Stability Study of Plastic and Rubber Pharmaceutical Packaging Materials. This guideline comprises part of the results of a research project organized by ChPC in 2016 and is one of the actions taken by National Drug Administration of China (formerly the China Food and Drug Administration, CFDA) to support the previously announced Opinions on Reforming the Review and Approval System for Drugs and Medical Devices (No. 44).
Compendial documents developed by both international and national organizations outline specifications for elastomeric components that are used in packaging of parenteral drug products. These specifications often are not harmonized; not all compendia specify the use of the same tests, and some tests that are used globally have varying specifications. Understanding these specifications and how they influence packaging/delivery of parenteral drug products in global markets is critical.
Last week, West once again exhibited at CPhI/Innopack—Europe’s premier trade show that brings together approximately 36,000 senior pharmaceutical professionals from more than 150 countries. West was among the show exhibitors that included providers of packaging, finished doses, machinery, ingredients, contract services, and other related services.
Nuclear medicine has been extensively used not only to diagnose but also to treat diseases. Radio-labeled proteins and peptides are widely used for this purpose, and glass vials have been traditionally used to store radio-labeled pharmaceutical parenteral dosage forms. One important factor for successful use of the container closure systems (CCS) is how precisely and efficiently the radiopharmaceutical solution is withdrawn from the sealed container. However, due to the generally hydrophobic nature of these compounds, chemical reactions, including product synthesis and purification processes, are often complicated and costly. Overcoming the potential for adsorption of these compounds to the surface of the CCS is key to maximizing the effectiveness of radiopharmaceuticals.
Randy Adachi, Dir, Technical Ops, Daikyo
Eric Kurtz, Sr. Specialist, Technical Product Development