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US 2023/0054413 A1Published application
Stable anti-pd1 antibody pharmaceutical formulations
AssigneeSamsung Bioepis Co., Ltd.
InventorsYoung Seok JUNG, Ja Hye HONG, Kyung Hee JOO, Young Wook HA, In Young OH, In Ae KIM
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Abstract
The present disclosure relates to a stable anti-PD-1 antibody pharmaceutical formulation and a method for preparing the same, the pharmaceutical formulation comprising: an anti-PD-1 antibody or an antigen binding fragment thereof; and a stabilizer, and not comprising a buffer.
Claims20
A stable anti-PD-1 antibody pharmaceutical formulation, comprising:
- (a) an anti-PD-1 antibody or an antigen binding fragment thereof;
- and
- (b) a stabilizer,
- wherein the formulation does not comprise a buffer and has a pH of about 4.5 to about 6.5.
1 more element
A method for preparing a stable pharmaceutical formulation, comprising:
- preparing a mixed solution by adding a stabilizer to a solvent;
- and adding a pembrolizumab or an antigen binding fragment thereof to the mixed solution, or
- comprising:
- preparing a solution of a pembrolizumab or an antigen binding fragment thereof by adding the pembrolizumab or the antigen binding fragment thereof to a solvent;
- and adding a stabilizer to the solution,
- wherein the method is performed without adding a buffer.
3 more elements
Dependencies are inferred from the claim text.