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Production method of recombinant adenovirus gene vaccine for preventing novel coronavirus

A technology of recombinant adenovirus and gene vaccine, which is applied in the field of biopharmaceutical technology, can solve the problems that cannot meet the requirements of large-scale industrialization of gene therapy products, and achieve the effect of large-scale industrialization

Pending Publication Date: 2020-08-07
SYNO SHENZHEN BIOMEDICAL RES CO LTD
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  • Abstract
  • Description
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  • Application Information

AI Technical Summary

Problems solved by technology

Traditional laboratory gene therapy product preparation methods can no longer meet the requirements of GMP large-scale industrialization of gene therapy products

Method used

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  • Production method of recombinant adenovirus gene vaccine for preventing novel coronavirus
  • Production method of recombinant adenovirus gene vaccine for preventing novel coronavirus

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Embodiment Construction

[0027] The technical solutions of the present invention will be further described in detail below in conjunction with the accompanying drawings and embodiments.

[0028] refer to figure 1 As shown, this embodiment is a production method of a recombinant adenovirus gene vaccine used to prevent new coronaviruses, using serum-free suspension cells to produce recombinant adenovirus, including the following steps:

[0029] 1. Cell expansion

[0030] Take 1 cell tube from the working cell bank of serum-free suspension cells, the cell volume is about 1x10 7 to 1x10 8 . Cells were thawed and inoculated into spinner bottles for cell culture at a seeding density of about 3x10 4 to 1x10 4 / ml. Cultivate in a 5% carbon dioxide incubator at 37°C. Spinner bottles were shaken at 50–150 rpm. Culture cells to a density of approximately 2x10 6 / ml, dilute the cell concentration to 2x10 with fresh medium 5 / ml, and expanded into larger spinner bottles, and continued to culture. Repeat...

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Abstract

The invention relates to a production method of a recombinant adenovirus gene vaccine for preventing the novel coronavirus. The production method comprises the following main steps: amplifying cells;performing inoculating in a bioreactor, carrying out perfusion culturing in a culture solution, and carrying out cell re-amplification; diluting the cells and transferring the processed cells to a large-volume bioreactor; infecting and amplifying the recombinant adenovirus; harvesting the recombinant adenovirus culture solution and then performing filtering and concentrating; performing nuclease treatment; carrying out full-automatic ion exchange column chromatography separation and purification; and preparing, filling and freeze-drying the product. The method provided by the invention has good amplification and economy, can meet various technical requirements of medical monitoring organizations on GMP production, and fully ensures the quality and biological activity of the product.

Description

technical field [0001] The invention belongs to the field of biopharmaceutical technology, and relates to a production method of a recombinant adenovirus gene vaccine used to prevent novel coronavirus, and a large-scale production method of a GMP-compliant recombinant adenovirus vector gene vaccine product. Background technique [0002] The outbreak of the novel coronavirus (COVID-19) has brought a huge crisis to social public health, and the infection is very contagious, which has caused huge social health and economic impacts on human beings, and is highly valued by people. There is currently no effective treatment and preventive vaccine. For the health of the people, the security of the country and society, there is an urgent need to develop vaccine products that can prevent novel coronavirus infection. [0003] Commonly used virus vaccine development methods include 1) inactivated virus vaccines, 2) attenuated virus vaccines, 3) subunit vaccines, 4) VLP (virus like part...

Claims

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Application Information

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IPC IPC(8): A61K39/215A61P31/14
CPCA61K39/12A61P31/14C12N2770/20034A61K2039/5256
Inventor 徐卫
Owner SYNO SHENZHEN BIOMEDICAL RES CO LTD
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