Journal of East China Normal University(Natural Science) ›› 2021, Vol. 2021 ›› Issue (3): 114-127.doi: 10.3969/j.issn.1000-5641.2021.03.012

• Life Sciences • Previous Articles     Next Articles

Preparation and stability study of lyophilized lentiviral vector

Hongwei SHEN, Minghao LI, Nan XU, Jiaqi SHAO, Jing WANG, Lei YU*()   

  1. School of Chemistry and Molecular Engineering, East China Normal University, Shanghai 200062, China
  • Received:2019-12-25 Online:2021-05-25 Published:2021-05-26
  • Contact: Lei YU


In this paper, we studied a new preparation technique for lyophilized lentiviral vectors. We determined the optimal formulation for a freeze-drying protective agent by screening and optimizing potential candidates. The candidates were evaluated on the basis of physical and chemical properties of the freeze-drying process, including appearance, excipient, color, and solubility. The optimal formulation was determined to be trehalose 0.30 g/mL, L-histidine 0.31 mg/mL, L- alanine 0.178 mg/mL, CaCl2 0.020 mg/mL, and MgSO4 0.015 mg/mL. With this technique, the prepared lyophilized lentiviral vector had good appearance, low residual water content, intact structure, and good re-dispersibility. The biological titer of the lentiviral vector reached 9.37 × 107 IU/mL, and the recovery rate of the titer was 50.15%. We also conducted research on potential influencing factors, including a high temperature accelerated experiment and repeated freeze-thaw stability experiments. These experiments showed that the lyophilizing technology can be used for the preparation of lentiviral vector solids and can be effectively used to improve the storage of lentiviral vectors under different temperature conditions, exposure to repeated freeze-thaw cycles, and tolerance to adverse environments (e.g., high temperatures).

Key words: lentiviral vector, lyophilized preparation, stability

CLC Number: