Assessing the stability-indicating properties of alternative potency assays for inactivated influenza vaccine

被引：4

作者：

Ekimov, Aleksei ^{[1
]}

Arunachalam, Arun B. ^{[2
]}

Blake, Taylor ^{[2
]}

Bodle, Jesse ^{[3
]}

Couzens, Laura ^{[4
]}

Dubey, Sitara ^{[5
]}

Eichelberger, Maryna ^{[4
]}

Engelhardt, Othmar G. ^{[6
]}

Gubinelli, Francesco ^{[5
]}

Joshi, Manju ^{[4
]}

Melnyk, Darya ^{[4
]}

Palladino, Giuseppe ^{[7
]}

Rigsby, Peter ^{[8
]}

Rockman, Steven ^{[3
]}

Savina, Natalya ^{[1
]}

Smith, Elena ^{[9
]}

Gilchrist, Shawn A. N. ^{[10
]}

机构：

[1] Fed Med Biol Agcy FMBA Russia, Dept New Technol, St Petersburg Sci Res Inst Vaccines & Serums SPbSR, Fed State Unitary Enterprise FSUE, St Petersburg 198320, Russia

[2] R&D Sanofi, Global Analyt Sci, 1 Discovery Dr, Swiftwater, PA 18370 USA

[3] Seqirus Ltd, Tech Dev & Global Proc Innovat, 63 Poplar Rd, Parkville, Vic 3052, Australia

[4] US FDA, Ctr Biol Evaluat & Res CBER, Div Biol Stand & Qual Control DBSQC, Off Compliance & Biol Qual, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA

[5] Med & Healthcare Prod Regulatory Agcy, Stand Lifecycle Sci Res & Innovat, Blanche Lane, South Mimms, Potters Bar EN6 3QG, England

[6] Med & Healthcare Prod Regulatory Agcy, Vaccines Sci Res & Innovat, Blanche Lane, Potters Bar EN6 3QG, England

[7] Seqirus, Preclin Res, 50 Hampshire St,9th Floor, Cambridge, MA 02139 USA

[8] Med & Healthcare Prod Regulatory Agcy, Analyt & Biol Sci, Sci Res & Innovat, Blanche Lane, Potters Bar EN6 3QG, England

[9] Sanofi, Vaccine mRNA Ctr Excellence, Analyt CMC, 200 West St, Waltham, MA 02451 USA

[10] S Gilchrist Consulting Serv Inc, 8 Covebank Crescent, Brampton, ON L6P 2X5, Canada

来源：

VACCINE | 2023年 / 41卷 / 32期

关键词：

Influenza potency testing; Influenza vaccines; SRID; Influenza vaccine potency; Stability; Alternate influenza potency assays; Immunogenicity; HEMAGGLUTININ; IMMUNOASSAY;

D O I：

10.1016/j.vaccine.2023.06.051

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

Determination of the potency of a vaccine is critical to ensuring that an appropriate dose is delivered, lotto-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. Crown Copyright & COPY; 2023 Published by Elsevier Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

引用

页码：4639 / 4647

页数：9

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