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West’s Tibor Hlobik will present a poster at the 2014 PDA Universe of PFS and Injection Devices Conference at the Hyatt Regency Huntington Beach Resort & Spa, Huntington Beach, California, on October 6-7, 2014. The poster presentation will take place on October 7, at 10:00 a.m.
Companies developing biotechnology products in a prefilled syringes are faced with a highly competitive market in leading therapeutic categories. As a result, all players have to implement new strategies to continuously improve their existing drug brands as part of lifecycle management or introduce new, superior products with better patient outcomes. At the same time, these manufacturers are challenged to reduce total unit cost, increase quality levels and ensure dose accuracy. Plungers play a key role in these new strategies and must be carefully selected especially with auto-injector drug delivery formats. Costly issues such as particle contamination, high levels of leachables forming during long term storage, and poor dose delivery performance can be avoided by selecting the right plunger product. In this presentation, attendees will learn about the latest plunger technology including Quality by Design options that address drug development challenges, quality risks and that optimize reliability of self injection devices in a highly competitive market.
Elastomer plungers are complex components and many times overlooked during selection of prefilled syringes especially when used in an auto-injector to deliver biologics. The intent of the presentation is to educate the audience on new technology options, user requirements that must be considered, and how to make the best plunger selection using a risk based approach.
Visit West at Booth #210 on October 6-7 to learn more.
West is a proud exhibitor at this event, and representatives will be on hands to demonstrate technologies and customer solutions for self-injection, administration, packaging systems and components. In addition to Tibor’s poster presentation, Graham Reynolds will present at the event:
One of the challenges a drug manufacturer faces is controlling the drug product at the point-of-use in a hospital or clinical environment. Often the method of vial access is variable, leading to an increased risk of harmful patient outcomes such as stopper cores or fragments entering into the drug product, which can contribute to cardiovascular events. There are a number of causes that contribute to stopper coring and fragmentation in the field that depend primarily on the technique of the practitioner and the properties of the elastomeric closure.
Cell and gene therapies are an expanding area with an expected growth rate of 24.7% over the forecast period of 2022-2030 .<sup>1</sup><br />Vial-stopper-seal combinations used as containment systems for these therapies need to maintain container closure integrity (CCI) for extended periods. Achieving CCI can be a particular challenge due to the low storage temperatures required: ultra-low (-80°C) for gene therapies and cryogenic (≤ -130°C, i.e., vapor of liquid nitrogen) for cell therapies.
Recently, there has been discussion in the industry regarding the utility of polymer-based vial containment systems for the storage and transport of gene therapy drug products, which can be performed as low as -80<sup>o</sup>C. Since it is known that all polymers are gas permeable, discussion has centered on whether polymer-based systems can sufficiently restrict ingress of oxygen (during refrigerated storage) and carbon dioxide (during transport on dry ice).
As biologics and other injectable drug products gain market share, greater scrutiny is being paid to the interaction between the drug product and its container closure system, including stability during shelf-life and particulate burden, among other critical quality attributes. Over the last several years, drug product recalls have increased due to quality issues, including fundamental weaknesses in primary glass containers that have resulted in problems such as breakage or delamination. Additionally, as more attention is paid to the integration of primary drug containers with devices to form combination products, finding solutions to these problems has taken on an increased urgency in order to protect patients by assuring the integrity and proper delivery of drug products.
Since the Technical Guideline on Compatibility Study of Chemicals and Elastomeric Closures was published by the National Medical Products Administration (NMPA, previously known as CFDA) in April 2018, it is essential for pharmaceutical companies to perform compatibility studies. However, for some domestic pharmaceutical companies that lack experience, it is unclear how to perform such a study. To address this, a series of trainings was planned by China National Pharmaceutical Packaging Association (CNPPA) – with the first held in December 2018. There were over 100 attendees from pharmaceutical companies, pharmaceutical packaging companies, NMPA-affiliated labs, and the third-party labs. The training received positive feedback from the participants.
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