Method Of Preparing A Therapeutic Protein Formulation And Antibody Formulation Produced By Such A Method

    公开(公告)号:US20230134160A1

    公开(公告)日:2023-05-04

    申请号:US15761777

    申请日:2016-09-08

    申请人: PFIZER INC.

    摘要: The invention relates to a method of preparing a protein formulation including a therapeutic protein, the method comprising the steps of: providing a solution comprising said protein; concentrating the protein in the solution by a first ultra-filtration step; diafiltering the solution with a diafiltration buffer including at least one first excipient, whereby a retentate is obtained comprising the protein and the first excipient; further concentrating the protein in the retentate by a second ultra-filtration step; and adding at least one final excipient, whereby the protein formulation with a desired protein concentration is obtained. According to the inven tion, the method further comprises, before the second ultra-filtration step, adding a second excipient to the retentate obtained from the diafiltration step. The invention is also directed to antibody formulations produced by the foregoing method.

    ONCE DAILY CANCER TREATMENT REGIMEN WITH A PRMT5 INHIBITOR

    公开(公告)号:US20230043985A1

    公开(公告)日:2023-02-09

    申请号:US17786695

    申请日:2020-12-15

    申请人: Pfizer Inc.

    摘要: A method of treating cancers, including pancreatic cancer, endometrial cancer, non-small cell lung cancer (NSCLC), endometrial cancer, cervical cancer, bladder cancer, head and neck squamous cell carcinoma (HNSCC), urothelial carcinoma, esophageal cancer, and other cancers, the method comprising once-daily administration, to a patient in need thereof, of a therapeutically effective amount of (1S,2S,3S,5R)-3-((6-(difluoromethyl)-5-fluoro-1,2,3,4-tetrahydroiso quinolin-8-yl)oxy)-5-(4-methyl-7H-pyrrolo[2,3-d]pyrimidin-7-yl) cyclopentane-1,2-diol having the structure: Formula I or a pharmaceutically acceptable salt thereof.