Previous Blogs

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By Page McAndrew PhD.

October 30, 2020

Cell therapies are stored at cryogenic temperature (approximately -180oC, vapor of liquid nitrogen). By providing container closure integrity (CCI) under this condition, primary package systems based on Daikyo Crystal Zenith® cyclic olefin polymer (COP) vials have a clear advantage over systems based on glass vials.

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By Mike Schaefers

February 06, 2020

Our team will share their expertise and introduce several new and innovative pharmaceutical containment and closure offerings during the Paris Pharmapack trade show.

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By Amy Kim,

November 18, 2019

The FDA recognizes that compounded drugs serve an important role for patients whose medical needs cannot be met by FDA-approved drugs. However, compounded drugs are not approved by the FDA and therefore, have not been evaluated for safety or efficacy. Poor compounding practices or unsuitable manufacturing conditions can lead to serious adverse effects, or even patient death. Over the past few years, the FDA has taken significant steps to modernize and clarify policies related to the quality of compounding in an effort to ensure continued access to compounded drugs, while also protecting patients from the risks of contaminated or otherwise harmful products1. FDA Draft Guidances2, 3 help to clarify applicable regulatory requirements and specifically address the use and handling of container closure systems.

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By Page McAndrew Ph,D,

September 12, 2019

Gene and cell therapies require cryo storage – approximately -80oC for genes, and approximately -180oC (i.e., vapor of liquid nitrogen) for cells. This requirement places a very high demand on the packaging to provide both good container closure integrity (CCI) and preservation of drug product viability.

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By Nico Brandes

March 21, 2019

The global injectable drug market sees an ever-increasing adoption of high-value biologic drug products. More than half of today’s 20 top selling injectables are biologics, and many of them are delivered in a prefilled syringe. Even though glass syringes are predominantly used for primary containment of parenterals, the (bio)pharmaceutical industry continues to cope with certain limitations associated with glass prefilled systems.