June 12 – 17, 2022
Rotavirus A infection is a global leading cause of severe acute gastroenteritis associated with most of life-threatening diarrhoea episodes in infants and young children. However, the disease burden is being reduced namely due to wider access to rotavirus vaccines and their inclusion into National Immunization Programs of several countries. Besides being live-saving, rotavirus vaccination has an important economic impact, being cost-effective or even cost-saving in some countries. Nevertheless, vaccines are not yet routinely available in all countries. There is a demand to expand the rotavirus vaccination programs and improved analytical tools for high-throughput in-process product quality control and vaccine manufacturing will be important in this context. Moreover, this can be also useful for current marketed vaccines to support their life cycle.
In this work, we present the development of two analytical tools for the quantification of rotavirus particles contained in a licensed vaccine. In-process and drug product samples were evaluated using biolayer interferometry analysis, applied on an Octet platform, and flow cytometry, respectively.
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Sofia B. Carvalho, Mafalda M. Dias, Jean-Philippe Matheise, Guillaume Van Beersel, Isabelle Knott, Patrícia Gomes-Alves, and Paula M. Alves, "Bioanalytical tools for the quantification of in-process and final product samples of a rotavirus vaccine" 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/82