Viral inactivation methods for continuous manufacturing of antibodies
AssigneeBayer HealthCare LLC
InventorsShengjiang Liu, June Xiaojun Zou, Janice Hsiu Mei Lee
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Abstract
This disclosure relates to methods for use in inactivating viruses. The virus inactivation methods are for use in continuous process manufacturing of a biologic such as an antibody, and include separating an eluate using a column, subjecting said eluate to an orthogonal treatment of low pH and detergent simultaneously wherein, the time for viral inactivation is reduced. In addition, the detergent can be added to buffer system in purification process to achieve the same effect. The biologic in each treatment case is retained.
Claims11
A virus inactivation method for use in continuous process manufacturing of a biologic, comprising:
- (a) separating an eluate with a biologic and active virus using a column;
- (b) subjecting said eluate with said active virus to an orthogonal treatment of low pH, wherein the pH is from 3 to 4, and a Mega-10 non-ionic detergent, wherein Mega-10 is a N-Methylglucamide, simultaneously to inactivate said virus;
- wherein the time for viral inactivation of the eluate is reduced as compared to the separate treatment time of the eluate using low pH or the Mega-10 non-ionic detergent, the biologic is retained, wherein the virus comprises enveloped viruses, in a family selected from the group consisting of:
- Retroviridae, Flaviviridae-, Togaviridae, Coronaviridae, Filoviridae, Rhabdoviridae, Bunyaviridae, Orthomyxoviridae, Paramyxoviridae, Arenaviridae, Hepadnaviridae, Herpesviridae, Baculoviridae and Poxviridae, and the Mega-10 non-ionic detergent concentration is in the range of from 0.05-1%(w/v).
Dependencies are inferred from the claim text.