tetano
Editor, Senior Moderator
Vaccine
. 2023 Jun 19;S0264-410X(23)00726-0.
doi: 10.1016/j.vaccine.2023.06.051. Online ahead of print. Assessing the stability-indicating properties of alternative potency assays for inactivated influenza vaccine
Aleksei Ekimov[SUP] 1 [/SUP], Arun B Arunachalam[SUP] 2 [/SUP], Taylor Blake[SUP] 3 [/SUP], Jesse Bodle[SUP] 4 [/SUP], Laura Couzens[SUP] 5 [/SUP], Sitara Dubey[SUP] 6 [/SUP], Maryna Eichelberger[SUP] 7 [/SUP], Othmar G Engelhardt[SUP] 8 [/SUP], Francesco Gubinelli[SUP] 9 [/SUP], Manju Joshi[SUP] 10 [/SUP], Darya Melnyk[SUP] 11 [/SUP], Giuseppe Palladino[SUP] 12 [/SUP], Peter Rigsby[SUP] 13 [/SUP], Steven Rockman[SUP] 14 [/SUP], Natalya Savina[SUP] 15 [/SUP], Elena Smith[SUP] 16 [/SUP], Shawn A N Gilchrist[SUP] 17 [/SUP]; World Health Organization's Pandemic Influenza preparedness, Vaccine Response's Alternative Potency, Reagents Technical Working Group
Affiliations
Determination of the potency of a vaccine is critical to ensuring that an appropriate dose is delivered, lot-to-lot consistency is maintained, and that the formulation is stable over the life of the vaccine. The potency of inactivated influenza vaccines is determined routinely by the Single Radial Immunodiffusion (SRID) assay. A number of alternative potency assays have been proposed and have been under evaluation in recent years. The aim of this study was to compare a surface plasmon resonance-based assay and two different enzyme linked immunoassays against the current potency assay, SRID, and against mouse immunogenicity when haemagglutinin antigen of the A(H1N1)pdm09 component of an inactivated influenza vaccine is stressed by elevated temperature, low pH and freezing. This analysis demonstrated that the alternative assays had good correspondence with SRID for samples from most stress conditions and that the immunogenicity in mice corresponded with potency in SRID for all stress samples. Subject to further analysis, the assays have been shown to have the potential to possibly replace, and at least complement, SRID.
Keywords: Alternate influenza potency assays; Immunogenicity; Influenza potency testing; Influenza vaccine potency; Influenza vaccines; SRID; Stability.
. 2023 Jun 19;S0264-410X(23)00726-0.
doi: 10.1016/j.vaccine.2023.06.051. Online ahead of print. Assessing the stability-indicating properties of alternative potency assays for inactivated influenza vaccine
Aleksei Ekimov[SUP] 1 [/SUP], Arun B Arunachalam[SUP] 2 [/SUP], Taylor Blake[SUP] 3 [/SUP], Jesse Bodle[SUP] 4 [/SUP], Laura Couzens[SUP] 5 [/SUP], Sitara Dubey[SUP] 6 [/SUP], Maryna Eichelberger[SUP] 7 [/SUP], Othmar G Engelhardt[SUP] 8 [/SUP], Francesco Gubinelli[SUP] 9 [/SUP], Manju Joshi[SUP] 10 [/SUP], Darya Melnyk[SUP] 11 [/SUP], Giuseppe Palladino[SUP] 12 [/SUP], Peter Rigsby[SUP] 13 [/SUP], Steven Rockman[SUP] 14 [/SUP], Natalya Savina[SUP] 15 [/SUP], Elena Smith[SUP] 16 [/SUP], Shawn A N Gilchrist[SUP] 17 [/SUP]; World Health Organization's Pandemic Influenza preparedness, Vaccine Response's Alternative Potency, Reagents Technical Working Group
Affiliations
- PMID: 37344260
- DOI: 10.1016/j.vaccine.2023.06.051
Determination of the potency of a vaccine is critical to ensuring that an appropriate dose is delivered, lot-to-lot consistency is maintained, and that the formulation is stable over the life of the vaccine. The potency of inactivated influenza vaccines is determined routinely by the Single Radial Immunodiffusion (SRID) assay. A number of alternative potency assays have been proposed and have been under evaluation in recent years. The aim of this study was to compare a surface plasmon resonance-based assay and two different enzyme linked immunoassays against the current potency assay, SRID, and against mouse immunogenicity when haemagglutinin antigen of the A(H1N1)pdm09 component of an inactivated influenza vaccine is stressed by elevated temperature, low pH and freezing. This analysis demonstrated that the alternative assays had good correspondence with SRID for samples from most stress conditions and that the immunogenicity in mice corresponded with potency in SRID for all stress samples. Subject to further analysis, the assays have been shown to have the potential to possibly replace, and at least complement, SRID.
Keywords: Alternate influenza potency assays; Immunogenicity; Influenza potency testing; Influenza vaccine potency; Influenza vaccines; SRID; Stability.