Development and characterization of standard reagents for cell-based prepandemic influenza vaccine products

Lai, Chung K.; Weng, Tsai-Chuan; Chen, Po-Ling; Tseng, Yu-Fen; Lin, Chun-Yang; Chia, Min‐Yuan; Sung, Wang-Chou; Lee, Min-Shi; Hu, Alan Yung-Chih

doi:10.1080/21645515.2020.1721223

Cited by 4 publications

(2 citation statements)

References 31 publications

(49 reference statements)

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“…Protein content was measured by Lowry assay (Pierce™ Modified Lowry protein assay kit, Thermo Fisher Scientific) and HA contents were measured by using single radial immunodiffusion (SRID) [ 12 ] with the WHO standard reagents. If the WHO standard reagents were not available, HA content was measured by using densitometry of SDS-PAGE [ 13 ].…”

Section: Methodsmentioning

confidence: 99%

Development and Evaluation of Vero Cell-Derived Master Donor Viruses for Influenza Pandemic Preparedness

Chen

Tzeng

et al. 2020

Vaccines

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The embryonated egg-based platform currently produces the majority of seasonal influenza vaccines by employing a well-developed master donor virus (MDV, A/PR/8/34 (PR8)) to generate high-growth reassortants (HGRs) for A/H1N1 and A/H3N2 subtypes. Although the egg-based platform can supply enough seasonal influenza vaccines, it cannot meet surging demands during influenza pandemics. Therefore, multi-purpose platforms are desirable for pandemic preparedness. The Vero cell-based production platform is widely used for human vaccines and could be a potential multi-purpose platform for pandemic influenza vaccines. However, many wild-type and egg-derived influenza viruses cannot grow efficiently in Vero cells. Therefore, it is critical to develop Vero cell-derived high-growth MDVs for pandemic preparedness. In this study, we evaluated two in-house MDVs (Vero-15 and VB5) and two external MDVs (PR8 and PR8-HY) to generate Vero cell-derived HGRs for five avian influenza viruses (AIVs) with pandemic potentials (H5N1 clade 2.3.4, H5N1 clade 2.3.2.1, American-lineage H5N2, H7N9 first wave and H7N9 fifth wave). Overall, no single MDV could generate HGRs for all five AIVs, but this goal could be achieved by employing two in-house MDVs (vB5 and Vero-15). In immunization studies, mice received two doses of Vero cell-derived inactivated H5N1 and H7N9 whole virus antigens adjuvanted with alum and developed robust antibody responses.

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Section: Methodsmentioning

confidence: 99%

Development and Evaluation of Vero Cell-Derived Master Donor Viruses for Influenza Pandemic Preparedness

Chen

Tzeng

et al. 2020

Vaccines

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“…was detected using electron micrographs, virtually pure PLS (less than 5% non-viral proteins) was successfully prepared (33). As the purity of PLS is important for the accurate determination of vaccine potency (34), it is necessary to devise a reliable alternative method for measuring the HA content by improving the technique for increasing the degree of HA purification. The antiserum is prepared by immunising sheep with HA prepared from prototype viruses or their derivatives, whereas the standard reference antigens, which are used to determine the HA content of the vaccine, must be derived from the strain used in the vaccine.…”

Section: Development Of In-vitro Potency Testing Methods For Cellbase...mentioning

confidence: 99%

Developments and current challenges in the process of cell culture-based seasonal influenza vaccine manufacture in Japan

Hamamoto

2024

GHM

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Seasonal influenza is an acute respiratory infection primarily caused by influenza A and B viruses, which circulate annually and cause substantial morbidity and mortality worldwide. Annual influenza vaccination is currently the most effective measure for preventing influenza and greatly reduces the risk of disease severity and the incidence of complications and death. Annual seasonal influenza vaccines are traditionally produced in Japan and many other countries using viruses propagated in embryonated chicken eggs. However, at present, the effectiveness of the seasonal influenza vaccines has some significant limitations, partly because of egg-adaptive mutations in the antigenic sites of the influenza virus haemagglutinin, which are caused by the continued evolution of seasonal influenza viruses. To overcome the limitations of egg-based influenza vaccine production, a mammalian cell culture-based influenza vaccine production system has been developed in Japan in the past decade as an alternative to the current production method. In this review, I have summarised the progress in the development of cell-based seasonal influenza vaccines and discussed the technological challenges encountered in the development of influenza vaccines.

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Quantification methods for viruses and virus-like particles applied in biopharmaceutical production processes

Lothert

Eilts

Wolff

2022

Expert Review of Vaccines

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Development and characterization of standard reagents for cell-based prepandemic influenza vaccine products

Abstract: (2020): Development and characterization of standard reagents for cell-based prepandemic influenza vaccine products, Human Vaccines & Immunotherapeutics,

Cited by 4 publications

References 31 publications

Development and Evaluation of Vero Cell-Derived Master Donor Viruses for Influenza Pandemic Preparedness

Development and Evaluation of Vero Cell-Derived Master Donor Viruses for Influenza Pandemic Preparedness

Developments and current challenges in the process of cell culture-based seasonal influenza vaccine manufacture in Japan

Quantification methods for viruses and virus-like particles applied in biopharmaceutical production processes

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