Evaluation of the Robustness Verification of Downstream Production Process for Inactivated SARS-CoV-2 Vaccine and Different Chromatography Medium Purification Effects.

Evaluation of the Robustness Verification of Downstream Production Process for Inactivated SARS-CoV-2 Vaccine and Different Chromatography Medium Purification Effects.

Publication date: Jan 06, 2024

Large-scale vaccine production requires downstream processing that focuses on robustness, efficiency, and cost-effectiveness. To assess the robustness of the current vaccine production process, three batches of COVID-19 Omicron BA. 1 strain hydrolytic concentrated solutions were selected. Four gel filtration chromatography media (Chromstar 6FF, Singarose FF, Bestarose 6B, and Focurose 6FF) and four ion exchange chromatography media (Maxtar Q, Q Singarose, Diamond Q, and Q Focurose) were used to evaluate their impact on vaccine purification. The quality of the vaccine was assessed by analyzing total protein content, antigen content, residual Vero cell DNA, residual Vero cell protein, and residual bovine serum albumin (BSA). Antigen recovery rate and specific activity were also calculated. Statistical analysis was conducted to evaluate process robustness and the purification effects of the chromatography media. The statistical analysis revealed no significant differences in antigen recovery (p = 0. 10), Vero HCP residue (p = 0. 59), Vero DNA residue (p = 0. 28), and BSA residue (p = 0. 97) among the three batches of hydrolytic concentrated solutions processed according to the current method. However, a significant difference (p < 0. 001) was observed in antigen content. The study demonstrated the remarkable robustness of the current downstream process for producing WIBP-CorV vaccines. This process can adapt to different batches of hydrolytic concentrated solutions and various chromatography media. The research is crucial for the production of inactivated SARS-CoV-2 vaccines and provides a potential template for purifying other viruses.

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Concepts Keywords
Chromatography anion-exchange chromatography
Downstream downstream process
Inactivated purification
Singarose SARS-CoV-2
Vaccine size-exclusion chromatography
Vero cells


Type Source Name
disease IDO production
disease IDO process
disease VO vaccine
disease VO efficiency
disease VO effectiveness
disease MESH COVID-19
disease IDO quality
disease IDO cell
drug DRUGBANK Human Serum Albumin
disease VO WIBP-CorV
disease VO Viruses
drug DRUGBANK Guanosine
drug DRUGBANK Coenzyme M
disease MESH Pneumonia
disease VO effective
disease VO vaccination
disease MESH reinfection
disease MESH infection
disease MESH cognitive impairment
disease MESH influenza
disease VO efficient
disease IDO host
disease VO vaccine candidate
disease VO inactivated vaccine
disease VO time
drug DRUGBANK Nitrogen
disease VO USA
drug DRUGBANK Oxygen
drug DRUGBANK Sulodexide
drug DRUGBANK Medical air
disease VO dose
disease VO titer
disease VO volume
drug DRUGBANK Trypsin
disease VO inactivation
drug DRUGBANK Propiolactone
drug DRUGBANK Water
drug DRUGBANK Medroxyprogesterone acetate
disease VO syringe
disease IDO assay
disease VO immunized
drug DRUGBANK Ilex paraguariensis leaf
drug DRUGBANK Trestolone
drug DRUGBANK Esomeprazole
disease MESH virus infection
disease IDO replication
drug DRUGBANK Isoxaflutole
disease MESH death
disease VO organ
drug DRUGBANK Carboxyamidotriazole
disease VO device
disease VO mouth
disease VO Glycoprotein
drug DRUGBANK Heparin
drug DRUGBANK Flunarizine
drug DRUGBANK Porphobilinogen
disease VO viral vaccine

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