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Gene therapies are stored and shipped at ultra-low temperature (approximately -80^oC, either in a refrigerator or on dry ice). This provides a challenge to the primary package systems in maintaining container closure integrity (CCI), especially systems comprising glass vials and elastomer stoppers. These materials have different coefficients of thermal expansion. Upon cooling from room temperature to ultra-low temperature, they contract at different rates; this may lead to gaps and CCI loss.

The overall quality of a final drug product depends on the components of its packaging and delivery systems.  The use of visually inspected components reduces the risk of defective components and helps ensure patient safety.

Developing a SARS-CoV-2 vaccine presents numerous and unprecedented challenges; prominent among them are greatly accelerated timelines. Ordinarily for a new drug product, there is sufficient time for selection/evaluation of the vial/stopper packaging system – one that guarantees quality and safety from manufacture through delivery. This is not the case for a SARS-CoV-2 vaccine where the primary packaging system must be chosen quickly, creating a higher risk.

The Packaging Academy has been organized by West in Asia Pacific for the past 5 years, beginning in 2015, and serves as a valued training platform for our customers in injectable packaging both in the areas of containment and delivery systems.

Selecting the right package for a drug product is essential. To do this, it is necessary to understand the surface chemistry of the components of the package to determine if any unwanted interaction with the drug product is likely.