公开(公告)号：US20240309073A1

公开(公告)日：2024-09-19

申请号：US18645135

申请日：2024-04-24

申请人： SERUM INSTITUTE OF INDIA PRIVATE LIMITED

发明人： Rajeev Mhalasakant DHERE ,  Sambhaji Shankar PISAL ,  Srinivas Reddy PEDDIREDDY ,  Digamber Singh CHAHAR ,  Lenna Ravinda YEOLEKAR ,  Pankaj Singh CHOUHANA ,  Nikhil Dattatray AVALASKAR ,  Adar Cyrus POONAWALA ,  Cyrus Soli POONAWALLA

IPC分类号： C07K16/10 ,  A61K9/19 ,  A61K39/395 ,  C12N5/078

CPC分类号： C07K16/1081 ,  A61K9/19 ,  A61K39/39525 ,  A61K39/39591 ,  C07K16/10 ,  C12N5/0634 ,  C07K2317/14 ,  C07K2317/92

摘要： The invention describes an efficient platform for antibody manufacturing and formulation that provides i) cell culture process with improved feeding strategy resulting in high antibody titer between 2 gm/L to 5 gm/L; ii) improved purification process showing optimal percentage recovery, high purity monomer content, minimum aggregation/particulate formation, minimum impurity levels; and iii) high concentration stable liquid formulation with optimal osmolality and low viscosity across different temperature excursions and devoid of aggregation. The preferred antibodies include IgG1 monoclonal antibody specific to the Dengue virus epitope in domain III of the E protein and IgG1 monoclonal antibody specific to the rabies virus surface G glycoprotein.