Preparation methods for a highly concentrated pd1 antibody solution by applying single-pass tangential flow filtration (sptff)
AssigneeBeOne Medicines I GmbH
InventorsYu JI, Xuening LI, Dawei ZHOU
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Abstract
The present disclosure provides for a preparation method of highly concentrated antibody solution that binds to human programmed death receptor 1 (PD1). This process is able to manufacture the high concentrated antibody solution by an ultrafiltration/diafiltration (UF/DF) unit operation described herein. The UF/DF preparation method comprises a single-pass tangential flow filtration (SPTFF) as the first ultrafiltration concentration step, a buffer solution diafiltration step and a second ultrafiltration concentration step using conventional UF/DF. The process has a broad operation parameter range and maintains antibody stability and integrity.
Claims24
An ultrafiltration (UF)/diafiltration (DF) process for a highly concentrated solution comprising a PD1 antibody or antigen binding fragment thereof, the process comprising the steps of:
- (a) ultrafiltrating the PD1 antibody or antigen binding fragment thereof in a process feed material to obtain an ultrafiltration 1 (UF1) pool protein with an intermediate antibody concentration through a single-pass tangential flow filtration (SPTFF) operation;
- (b) diafiltrating the UF1 pool protein from step (a) with diafiltration (DF) buffer into a final drug substance formulation buffer, to obtain a DF pool;
- (c) ultrafiltrating the DF pool from step (b) into a high concentration solution as an over concentrated pool with a desired concentration;
- and
- (d) adjusting the over concentrated pool to a final drug substance target concentration to prepare a UF2 pool, and then further diluting the UF2 pool to the highly concentrated solution.
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The process of claim 21, wherein the UF2 pool in step D is buffered with histidine.
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Dependencies are inferred from the claim text.