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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.
Understanding this challenge, West is focused on ensuring vial/stopper and syringe/plunger systems are suitable for low-temperature conditions. At the recent 2018 PDA Container Closure Performance and Integrity Conference, Matt Gehrmann, Senior Scientist, Scientific Communications, presented the poster Strategy to Evaluate CCI at Low Temperature. This discussed a three-fold strategy to address CCI at low-temperature storage conditions in glass/polymer vial and syringe systems paired with rubber stopper/plunger components. West’s strategy comprises deterministic methods endorsed in USP 1207 (Package Integrity Evaluation – Sterile Products):
West’s three-fold strategy allows for a more complete understanding of CCI performance of biologic drug containment and delivery systems in real-time, as well as over time. This supports not only regulatory compliance, but safe and efficient delivery of biologic drugs to patients. For more on West, visit the Knowledge Center or contact a Technical Customer Support (TCS) representative.
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 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.
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 />
Are you planning a container closure integrity (CCI) study, or making an addendum to an existing file? Make sure you are aware of the latest USP guidelines for testing prior to initiating a study.
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