FORMULATIONS BASED ON CD19 ANTIBODY Russian patent published in 2021 - IPC A61K39/395 C07K16/28 A61K47/12 A61K47/26 A61K47/36 A61K9/19 A61P35/00 

FIELD: biotechnology.

SUBSTANCE: group of inventions relates to biotechnology, namely to a pharmaceutical formulation based on an antibody to CD19 and its use for treatment of lymphoma or leukemia that express CD19. Stable lyophilized pharmaceutical formulation contains anti-CD19 antibody at a concentration of 20 mg/ml to 125 mg/ml, buffer, polysorbate at a concentration of 0.005% (w/v) to 0.06% (w/v) and with a pH amounting to 6.0, as well as a) trehalose at a concentration of 180 mM to 240 mM or b) mannitol at a concentration of 180 mM to 240 mM and sucrose at a concentration of 10 mM to 50 mM. CD19 antibody contains HCDR1 region with SEQ ID NO: 1, HCDR2 region with SEQ ID NO: 2, HCDR3 region with SEQ ID NO: 3, LCDR1 region with SEQ ID NO: 4, LCDR2 region with SEQ ID NO: 5, and LCDR3 region with SEQ ID NO: 6, heavy chain constant domain SEQ ID NO: 8, and light chain constant domain SEQ ID NO: 9.

EFFECT: lyophilized pharmaceutical formulation is stable at 2-8°С for at least 36 months.

43 cl, 5 tbl, 3 ex, 2 dwg