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Polymeric container systems are not new to the pharmaceutical industry, and their benefits in terms of break resistance, cosmetic quality and dimensional precision have been recognized by many companies around the world who have chosen to use a polymer vial or syringe.
More recently, issues such as protein aggregation, glass delamination, particles and the need for more precise and complex drug containers have led to an increased awareness and interest in polymer solutions as a preferred alternative to glass when considering new products. Increasing regulatory scrutiny of glass-related issues also has increased awareness of the potential risks to patients and the need to focus on safer solutions.
The various benefits of Daikyo Crystal Zenith® (CZ) cyclic olefin polymer systems, as well as a collaborative relationship among all parties can help create an effective integrated drug delivery system.
Dr. Nicolas Brandes
Business Development Manager Daikyo Crystal Zenith
Daikyo Crystal Zenith® is a registered trademark of Daikyo Seiko, Ltd.
Daikyo Crystal Zenith® technology is licensed from Daikyo Seiko, Ltd.
For many years, West has offered several ready-to-sterilize products that are qualified for a minimum 3-log Bacterial Endotoxin Reduction (BER). “Ready-to-sterilize” is known to West customers in Europe as “RS” quality. In other regions, such as South America or Asia, the ready-to-sterilize line of products includes our Superior Clean Product® (SCP) components and Enhanced Performance Products (EPP). These offerings reflect West’s commitment to quality components that support pharmaceuticals and biopharmaceuticals throughout the product lifecycle, while also fulfilling various regional market needs.
According to Health Resources & Services Administration (HRSA), in the US about 110,000 people are waiting for organs right now and about 20 patients die each day waiting for a transplant<sup>1</sup>. Due to shortage of donors and requirements for matching, there is a huge demand for manufactured tissues and organs. Bioprinting has emerged as a very promising tool for solving this major unmet need in healthcare.
On April 14, 2013, West celebrated its 90th anniversary. This landmark occasion commemorates our long history of working side-by-side with top pharmaceutical and biotechnology companies around the globe to meet the biggest challenges in delivering life-changing therapies safely and effectively to patients.
Recently, 16 of the interns from the 2019 West Ambassador Internship Program visited two West sites in Jersey Shore and Williamsport, Pennsylvania. As interns from the corporate headquarters, the tours of the two local manufacturing locations offered a unique perspective to contrast the corporate experience. During the Jersey Shore and Williamsport tours, the interns were given a different experience to visualize the making of the product itself.
<span>Understanding extractables and leachables (E&L) is an essential element of determining the suitability of a packaging or delivery system for a drug product. Recently, PDA presented an <a href="https://www.youtube.com/watch?v=mol_X2zQeig">interview with Dan Mellon, Ph.D., Pharmacology Toxicology Supervisor at CDER’s Office of New Drugs</a>, discussing FDA’s approach to evaluating E&L information </span>
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