Invention Grant
- Patent Title: Stable compositions of high-concentration allotype-selected antibodies for small-volume administration
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Application No.: US15592871Application Date: 2017-05-11
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Publication No.: US09963516B2Publication Date: 2018-05-08
- Inventor: Li Zeng , Rohini Mitra , Edmund A. Rossi , Hans J. Hansen , David M. Goldenberg
- Applicant: Immunomedics, Inc.
- Applicant Address: US NJ Morris Plains
- Assignee: Immunomedics, Inc.
- Current Assignee: Immunomedics, Inc.
- Current Assignee Address: US NJ Morris Plains
- Agent Richard A. Nakashima
- Main IPC: C07K16/30
- IPC: C07K16/30 ; C07K16/28 ; A61K51/08 ; A61K51/10 ; A61K39/00

Abstract:
Disclosed are methods, compositions and uses of high concentration antibody or immunoglobulin formulations for subcutaneous, intramuscular, transdermal or other local (regional) administration, in a volume of than 3, less than 2 or less than 1 ml. Preferably, the formulation contains a high concentration formulation (HCF) buffer comprising phosphate, citrate, polysorbate 80 and mannitol at a pH of about 5.2. The formulation more preferably comprises at least 100, 150, 200, 250 mg/ml or 300 mg/ml of antibody. The methods for preparing the high concentration formulation include ultrafiltration and diafiltration to concentrate the antibody and exchange the medium for HCF buffer. Other embodiments concern use of non-G1m1 (nG1m1) allotype antibodies, such as G1m3 and/or a nG1m1,2 antibodies. The nG1m1 antibodies show decreased immunogenicity compared to G1m1 antibodies.
Public/Granted literature
- US20170260287A1 Stable Compositions of High-Concentration Allotype-Selected Antibodies for Small-Volume Administration Public/Granted day:2017-09-14
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