Method for preparing a composition comprising highly concentrated antibodies by ultrafiltration
AssigneesChugai Seiyaku Kabushiki Kaisha, Genentech, Inc.
InventorsKelby Lau, Jean Bender, Saeko Tanaka, Rumiko Wakayama, Hidenari Yamada, Tomonori Isoda, Masayoshi Oh-Eda
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Abstract
The present invention provides a method for preparing a composition comprising highly concentrated antibodies by ultrafiltration in batch concentration mode having a first constant feed rate step and a second controlled feed rate step.
Claims29
A method for preparing a composition comprising highly concentrated antibodies by ultrafiltration, wherein the method comprises the steps of:
- concentrating an antibody preparation by ultrafiltrating the preparation, said ultrafiltrating comprising:
- 1) regulating a feed flow rate of the preparation to allow a value of a feed pressure applied to an ultrafiltration membrane to increase to 85-100% of a specified maximum feed pressure of the ultrafiltration membrane;
- and
- 2) decreasing the feed flow rate to maintain or decrease the value of the feed pressure applied to the ultrafiltration membrane after step (1),
- wherein the feed flow rate in step (1) is maintained at 250 LMH (L/m2/hour) or higher and the feed flow rate in step (2) is decreased to 80LMH (L/m2/hour) or lower and wherein the antibody preparation directly after said ultrafiltrating has an antibody concentration above 200 g/L or a viscosity above 10 mPas.
A method for preparing a composition comprising highly concentrated proteins by ultrafiltration, wherein the method comprises the steps of:
- concentrating a protein preparation by ultrafiltrating the preparation, said ultrafiltrating comprising:
- 1) regulating a feed flow rate of the preparation to allow a value of a feed pressure applied to an ultrafiltration membrane to increase to 85-100% of a specified maximum feed pressure of the ultrafiltration membrane;
- and
- 2) decreasing the feed flow rate to maintain or decrease the value of the feed pressure applied to the ultrafiltration membrane after step (1),
- wherein the feed flow rate in step (1) is maintained at 250 LMH (L/m2/hour) or higher and the feed flow rate in step (2) is decreased to 80 LMH (L/m2/hour) or lower and wherein the protein preparation directly after said ultrafiltrating has a protein concentration above 200 g/L or a viscosity above 10 mPas.
Dependencies are inferred from the claim text.