BTI scientists involved in the study: Dr. Zhang Wei (left) and Ms. Nur Izzati Bte Soonaan (right).
Dr. Zhang contributed to the conceptualization, design of the study and manuscript preparation. Ms. Nur Izzati Bte Soonaan designed and performed the experiments.
Traditionally, vaccine purification is a lengthy process to attain the high purity that helps to ensure patient safety. This study discovered that similar purity can be maintained even after selected steps are omitted, leading to a simplified and more efficient process. This is possible because a recently developed powerful purification tool was investigated and applied in a mode that is uncommonly used in conventional virus purification process.
Influenza is a public health concern as its virus spreads easily and evolves quickly. Therefore, the demand and pace for new influenza vaccines are extremely high, placing constant pressures on manufacturers. A key bottleneck in the production of influenza and other vaccines is downstream processing, wherein the inactivated viruses are decontaminated and purified. In this study, we shortened the traditional 7-step process to a 4-step process, significantly reducing cost and time for vaccine development and production. Our simplified process not only reduces risk points in biomanufacturing operations but also allows manufacturers to respond more nimbly to urgent needs, such as a pandemic.
H1N1 virus in the culture supernatant was directly captured using DBC and clarified using microfiltration only without any preconditioning. Under optimized conditions with a recently developed anion exchanger, 70-80% hemagglutinin recovery and >95% removal of host cell impurities were achieved in a single chromatographic step. Nuclease treatment, tangential-flow filtration prior to chromatography and polishing steps could be omitted without compromising end product quality, thus reducing the number of operational units and costs in the process. Our new process is applicable to chemically and heat-inactivated viruses alike with moderate recovery and good impurity removal without any further process optimization. It presents a viable and versatile alternative to existing chromatographic tools for the production of viral vaccines.
Generic downstream process for influenza virus purification.
Ta DT, Chu KL, Soonaan NIB, Chin C, Ng SK, Zhang W*. A new and simplified anion exchange chromatographic process for the purification of cell-grown influenza A H1N1 virus. Separation and Purification Technology 2021; 263, 118412.