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“Retro.” “Vintage.” “Nostalgic.” These can be great terms to describe that classic car you have your eye on, but they are not great when describing your primary drug product packaging. Many of today’s drug products are still packaged with elastomer formulations and designs that were first developed over 50 years ago. Generic companies that simply replicate the innovator packaging could be affecting their operation negatively for many more years to come.
Anyone in the generics industry knows that regulatory requirements can change frequently, and almost always to become more restrictive and more complex. The question is: “Can legacy packaging meet all the requirements of today’s ever-changing regulatory landscape?”
Regulation is not the only issue – so is performance. Many years ago, elastomer formulations were designed for operational efficiency. The quality standards were less rigorous and mass production was key. However, as the industry has evolved, formulations improved by employing cleaner raw materials, moving away from latex/dry natural rubber and optimizing designs to improve machinability. Legacy packaging can contribute to machinability failures and higher levels of rejects. Many customers that have learned to “work around” these issues will find it increasingly difficult to do so, as closed systems, such as isolator technology, are more widely adopted. Compounding regulatory and operational issues, legacy packaging components may become unavailable. These supply chain disruptions can put business and patient safety at risk.
To minimize issues with regulation, performance, and supply chain, it makes sense to switch to a modern elastomer formulation, such as the recently launched West AccelTRA™ 4031/45 gray component. The reauthorization of the Generic Drug User Fee Amendment (GDUFA II) changes planned for October, 2017 eliminate the fee currently associated with filing individual Prior Approval Supplements (PAS)1. This means there is one less barrier faced in order to make primary packaging changes. While making a switch can seem daunting – West can help – making the process much easier through the help of experts in technology and regulatory areas. Living with legacy items is no longer the only option. Contact West today for an evaluation of your current packaging selections as well as identification of any risks present. West can also support with samples, data and/or consultation needed to make the switch.
1. GDUFA II Fee Structure Summary:
Take an in-depth look at the science behind containment & delivery of injectable medicines in the West Knowledge Center.
West’s turns 100 today! A milestone that we are very proud of, and something few companies have the opportunity to celebrate. In honor of our 100th anniversary we are spotlighting our former President, Bill West, son of our founder Herman O. West.
The combination product market has seen a significant amount of growth,<sup>i</sup> driven primarily by the rise in chronic disease indications, the demands for self-administered therapies and technological advancements. The use of combination products simplifies the process of drug administration for the patient and/or the caregiver and, in some cases, allows the patient to receive treatment at home rather than having to travel to a medical facility. However, there are many challenges that need to be navigated as one considers the transition from a vial system to a needle-based combination product.
Administration of cell therapy drug products requires the delivery of cell suspensions without loss of function or viability. Cells must be transferred aseptically from their original container closure system to the administration system by infusion. However, the common transfer practice of using needles and syringes to pierce vial stoppers to retrieve contents poses a risk, namely needle-stick injury to clinicians.
As part of the annual West without Borders campaign, Tech Group Europe raised €30,000 (approximately $45,000) in 2013 for Temple Street Children’s University Hospital. The donation will be used to fund a much needed dialysis machine for the hospital’s renal unit.
Cell therapies offer a powerful new approach to treat cancer and other serious conditions. The manufacture and supply of these therapies is complex – to address the short shelf lives of such living products, storage and shipping is done at cryogenic temperatures (liquid nitrogen, approximately -180<sup>o</sup>C). A challenge is selecting the right container system.<br />