Abstract
A case study is presented for a vaccine drug product (DP) that showed variable re-dispersion times between syringes within a given DP lot and between different DP lots when shipped from the manufacturing site to the receiving site. A simulated shipping study was designed to understand the effect of individual shipping stresses on re-dispersion time and product quality. Shipping stresses simulating shock/drop, aircraft, and truck vibrations were applied separately to 3 syringe orientations, namely tip up, tip down, and tip horizontal (TH). Results from the simulated shipping study showed that shock/drop reduced re-dispersion time while truck and aircraft vibrations increased re-dispersion time in the tip down orientation. The dissimilar effects of different shipping stresses on re-dispersion resulted in the observed intra and inter DP lot variability in re-dispersion time. Shipping stresses did not impact re-dispersion in the TH or tip up orientation. No vaccine product quality attributes or physical properties were affected by shipping stresses. Actual shipping results correlated well with simulated shipping data. Because re-dispersion time was influenced mainly by shipping stress and syringe orientation, the mitigation measure to reduce end-user re-dispersion time was to implement the TH orientation for DP syringes during shipment and storage.
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