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With the growth of gene and cell therapies, there is an increased need to characterize container closure systems (CCS) at the low temperatures experienced during their lifecycles: ultra-low (-80°C) for genes and cryogenic (-180°C) for cells. West’s Integrated Solutions platform includes the state-of-the-art container closure integrity (CCI) capabilities needed for these therapies.
The FDA guidance for industry Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products* highlights the role of CCI evaluation in stability protocols for sterile drug products. The goal of CCI testing is to demonstrate that the package is well assembled, components have negligible defects, fit together, and are properly sealed – therefore proving that the system is maintaining product sterility and stability. Sealing performance may change as a CCS goes through temperature transitions. Leaks occurring at ultra-low or cryogenic temperatures might not be detected if CCI is measured only at room temperature. Therefore, CCI needs to be assessed at the temperature of storage and an appropriate CCI method needs to be selected to monitor CCI over time. West has the expertise and facilities to do this.
The United States Pharmacopoeia (USP) Chapter <1207> (Sterile Product – Package Integrity Evaluation) discusses the preference of using deterministic methods. The following are well suited to evaluate CCI of CCS for gene and cell therapy products:
This analytical toolbox helps ensure that the selected CCS is suitable to protect the gene or cell therapy at storage temperatures. This helps to ensure patient safety. West can perform all the testing discussed here and more!
For more information on West CCI capabilities visit the Container Closure Testing page or contact an Account Manager or Technical Customer Service (TCS) representative. West has recently generated a technical paper on ingress of gases into polymer vials to address questions a customer received from FDA on this topic. Visit the Knowledge Center for this and many other papers related to pharmaceutical packaging.
The FDA has approved over twenty (20) cell and gene therapy drugs, and with the rapid growth of the cell and gene therapy market, there is greater demand than ever to demonstrate container-closure integrity (CCI) at ultra-low temperatures. To preserve the product’s efficacy, most cell and gene therapy drugs are stored at temperatures below -60ºC. Many of these products are packaged in either vial systems or cryogenic freezing bags. While each of these container-closure systems poses a unique challenge for the evaluation of CCI at ultra-low temperatures, the discussion in this blog focuses specifically on vial systems.
Many complex biologic drug products, such as gene and cell therapies, require storage at low temperatures (from -60oC to -180oC). This presents a challenge for containment systems when maintaining container closure integrity (CCI) – especially for glass-rubber vial systems.
With the help of the FDA’s expedited programs for approval, a new wave of high-value biologic drugs is on the rise in the pharma industry.1 These drugs require cryogenic storage (-80oC to -180oC) to maintain stability. This presents a new challenge: how to measure and demonstrate container closure integrity (CCI) of storage and delivery systems at such low temperatures.<br />
In 2017 there were many changes in the Chinese pharmaceutical industry. China Food and Drug Administration (CFDA) has published several new regulations and guidelines – for example, <em>Technical Requirements for Consistency Evaluation on Marketed Chemical Generic Drugs (Injection) (Exposure Draft)</em> by Center for Drug Evaluation, CFDA. This addresses the point that consistency evaluations of drugs have been extended from oral medicines to injectable medicines. This will further help to improve pharmaceuticals quality in China, and of course, be of great interest to generics suppliers.<br />
With the advancement of high-value biologic,<span> gene, and cell therapy drugs, there is a growing interest in assessment of container closure systems (CCS) at the low temperatures experienced during processing, storage, and shipment. A vial-based CCS is usually capped at room temperature, but thereafter it may be exposed to low temperature conditions (0<sup>o</sup>C to -180<sup>o</sup>C), depending on both the drug characteristics and the expected duration of storage. </span>
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