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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.
Protein-based therapeutics are examples of the advancement of modern medicine and a revolution in drug discovery. Monoclonal antibodies (mAbs) account for the majority of biologic FDA approvals, and due to their low bioavailability by oral delivery means, they necessitate a shift to parenteral delivery. Hence, mAbs are typically packaged and stored in liquid or lyophilized format in glass vials, prefilled syringes, or cartridges for later injection.<br />
West has recently collaborated with a research team at the University of Washington (UW) led by Professor Shyam Gollakota to develop a wearable device to detect and reverse an opioid overdose.
With the prevalence of Non-alcoholic Steatohepatitis (NASH) rapidly increasing globally, West is working with its pharmaceutical partners to support their development of new injectable treatments for this serious liver condition. However, there are many challenges associated with trying to bring new treatments to market.<br />
Patrick Curran<sup>1</sup>, Vinod Vilivalam<sup>1</sup>, Suzanne Kuiper<sup>2</sup> and Derek Duncan<sup>2<br></sup><sup>1</sup>West Pharmaceutical Services, Inc. and <sup>2</sup>Lighthouse Instruments B.V.<p>An increasing number of pharmaceuticals including vaccines, stem cells and proteins require cold storage to maintain efficacy prior to use. However, the ability to maintain container closure integrity (CCI) during cold storage is not completely understood. </p>
“Waiter, what’s this fly doing in my soup?”<br>Answer: “The backstroke”
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