Live viral vaccines and gene and cell-based therapies sometimes require deep cold storage temperatures (-80 ˚C down to cryo) to maintain the activity and efficacy of the formulations. Studies have shown that these deep cold storage temperatures can introduce risk to the sealing performance of the packaging components. In particular, studies have shown that the low storage temperatures can introduce risk to the container closure integrity (CCI) of vial/rubber stopper combinations traditionally used to fill sterile pharmaceutical product.
In this webinar experts from Lighthouse Instruments and Genesis Packaging Technologies will describe how robust development work can be done in a holistic framework to choose the appropriate packaging components and to qualify the sealing process such that the risk of CCI issues during deep cold storage and transport is minimized.