Virus inactivation method, method for manufacturing protein drug, and system for purifying solution
AssigneesAble Corporation, National University Corporation Kobe University
InventorsKazuhisa Uchida, Shutaro Ishikawa, Satoshi Tomita, Kensaku Kanada
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Abstract
A virus inactivation method is provided. The method includes irradiating a solution containing an artificially expressed antibody or antibody fragment with ultraviolet rays in the presence of a radical scavenger. The irradiating only aggregates 5% or less of the antibody or antibody fragment. A wavelength of the ultraviolet rays is 200 nm or longer and 315 nm or shorter. An irradiation amount of the ultraviolet rays is 300 mJ/cm2 or more. An irradiation time of the ultraviolet rays is 3 minutes or less. A concentration of the radical scavenger in the solution is 0.03 mM or more.
Claims12
A virus inactivation method comprising irradiating a solution containing an artificially expressed antibody or antibody fragment with ultraviolet rays in the presence of a radical scavenger, wherein
- the irradiating only aggregates 5% or less of the antibody or antibody fragment,
- a wavelength of the ultraviolet rays is 200 nm or longer and 315 nm or shorter,
- an irradiation amount of the ultraviolet rays is 300 mJ/cm2 or more,
- an irradiation time of the ultraviolet rays is 3 minutes or less, and
- a concentration of the radical scavenger in the solution is 0.03 mM or more.
A method for manufacturing an antibody drug or an antibody fragment drug comprising:
- artificially expressing an antibody drug or an antibody fragment drug;
- and
- inactivating viruses contained in a solution containing the artificially expressed antibody drug or antibody fragment drug by irradiating the solution with ultraviolet rays in the presence of a radical scavenger, wherein
- the irradiating only aggregates 5% or less of the antibody or antibody fragment,
- a wavelength of the ultraviolet rays is 200 nm or longer and 315 nm or shorter,
- an irradiation amount of the ultraviolet rays is 300 mJ/cm2 or more,
- an irradiation time of the ultraviolet rays is 3 minutes or less, and
- a concentration of the radical scavenger in the solution is 0.03 mM or more.
A system for purifying a solution containing an artificially expressed antibody or antibody fragment, comprising:
- a first purification unit configured to purify the solution containing the artificially expressed antibody or antibody fragment by chromatography;
- a virus inactivation unit configured to irradiate the solution containing the antibody or antibody fragment resulting from the first purification unit with ultraviolet rays in the presence of a radical scavenger, the virus inactivation unit comprising:
- a channel having an inlet and an outlet for the solution and an ultraviolet-transmitting portion provided in at least a portion between the inlet and the outlet;
- and
- a light source configured to emit ultraviolet rays to the ultraviolet-transmitting portion;
- and
- a second purification unit configured to further purify, by chromatography, the solution containing the antibody or antibody fragment irradiated with the ultraviolet rays by the inactivation unit, wherein
- the irradiation of the solution containing the antibody or antibody fragment by the inactivation unit only aggregates 5% or less of the antibody or antibody fragment,
- a wavelength of the ultraviolet rays is 200 nm or longer and 315 nm or shorter,
- an irradiation amount of the ultraviolet rays is 300 mJ/cm2 or more,
- an irradiation time of the ultraviolet rays is 3 minutes or less, and
- a concentration of the radical scavenger in the solution is 0.03 mM or more, and
- the outlet of the channel of the inactivation unit is connected to an inlet of a column for the chromatography which the second purification unit comprises.
Dependencies are inferred from the claim text.