Methods for producing an active constituent of a pharmaceutical or a diagnostic agent in an MDCK cell suspension culture
AssigneeSeqirus UK Limited
InventorsJürgen Vorlop, Christian Frech, Holger Lübben, Jens-Peter Gregersen
Life of this patent
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Abstract
The present invention concerns a method for production of an active ingredient of a drug or diagnostic agent, in which (a) MDCK cells are infected with a virus; and (b) the MDCK cells are cultured in suspension culture on a commercial scale under conditions that permit multiplication of the viruses; in which culturing occurs in a volume of at least 30 L. The invention also concerns a method for production of a drug or diagnostic agent in which an active ingredient is produced according to the above method and mixed with an appropriate adjuvant, auxiliary, buffer, diluent or drug carrier.
Claims7
A method for production of a virus or a protein produced from the virus for use in manufacture of a viral vaccine on a commercial scale, comprising:
- (a) increasing the volume of a suspension culture of Madin-Darby Canine Kidney (MDCK) cells in a serum-free medium, a protein-free medium, or a chemically defined medium, in a fed-batch system by diluting with fresh medium to the suspension culture to increase its volume to at least 1000 L without removal of the original medium, wherein the fresh medium is added to the original medium to increase the volume of the suspension culture to the at least 1000 L such that the dilution is 1:10 to 1:2 original medium to fresh medium,
- (b) infecting the MDCK cells in the at least 1000 L volume with the virus,
- (c) propagating the viruses in the MDCK suspension culture, and
- (d) isolating the viruses or a protein produced from the viruses from the cell culture, wherein the virus is selected from the group consisting of an adenovirus, orthomyxovirus, paramyxovirus, reovirus, picornavirus, enterovirus, flavivirus, herpes virus and pox virus.
A method for production of a virus or a protein produced from the virus for use in manufacture of a viral vaccine on a commercial scale, comprising:
- (a) increasing the volume of a suspension culture of Madin-Darby Canine Kidney (MDCK) cells in a serum-free medium, a protein-free medium, or a chemically defined medium, in a fed-batch system by diluting with fresh medium to the suspension culture to increase its volume to at least 1000 L without removal of the original medium, wherein the fresh medium is added to the original medium to increase the volume of the suspension culture to the at least 1000 L such that the dilution is 1:10 to 1:2 original medium to fresh medium,
- (b) infecting the MDCK cells in the at least 1000 L volume with the virus,
- (c) propagating the viruses in the MDCK suspension culture, and
- (d) isolating the viruses or a protein produced from the viruses from the cell culture, wherein the virus is an influenza virus and the influenza virus used in step (b) is from a primary isolate that was pre-multiplied in cell culture to produce a pure isolate.
Dependencies are inferred from the claim text.