June 12 – 17, 2022
Long term vaccine stability at refrigerated temperatures (2-8°C and ambient) is critical to ensure a global reach of the vaccine using a standardized supply chain. During Ad26 clinical vaccine development, some instability at 2-8°C was observed which triggered a root cause investigation. There was a risk that the target shelf life of at least 2 years at 2-8°C would not be met.
The root cause was identified as adsorption of viral particles (vp’s) to the glass surface. This phenomenon is in particular observed upon inversion of the vial at 2-8°C due to the additional loss of vp’s to unexposed glass surface. Various innovative analytical tools were applied including spectroscopic kinetic monitoring of the loss of the vp’s directly inside the 2R glass vials. This was enabled by creating custom 3D printed accessories to fit the equipment. Models were created that allowed further predictions on the amount of vp’s adsorbed, dependent on volume, titer and vial type. Additional orthogonal analytical methods were applied to confirm the results, such as visualizing adsorbed material by dyes (staining) on the glass walls (Figure 1) as well as determining the vp content using VPqPCR and CZE.
Please click Download on the upper right corner to see the full abstract.
Martinus Capelle, Olga Labovitiadi, and Joao Calado da Silva Freire, "Improved Ad26 vaccine stability by mitigating interaction of viral particles with glass surfaces" in "Vaccine Technology VIII", Tarit Mukhopadhyay, Merck Research Laboratories, USA; Charles Lutsch, Sanofi Pasteur, France; Linda Hwee-Lin Lua, University of Queensland, Australia; Francesc Godia, Universitat Autònoma de Barcelona, Spain Eds, ECI Symposium Series, (2022). https://dc.engconfintl.org/vaccine_viii/78