Pen-injector device containing anti-IL-6 antibodies
A pen-injector device comprising an anti-IL-6 antibody with a liquid formulation have applications in diagnostic and/or therapeutic compositions, methods and devices.
1. A pen-injector device containing a liquid pharmaceutical formulation comprising an isolated IL-6 antibody having a light chain variable region and a heavy chain variable region, said light chain variable region comprising:
a complementarity determining region light chain 1 (CDRL1) amino acid sequence of SEQ ID NO:132 comprising the sequence S-X 1 -X 2 -X 3 -X 4 -V-X 5 -Y-M-Y, wherein X 1 is A or G, X 2 is S or R, X 3 is H, I, S, or Y, X 4 is S or Y, and X 5 is S or F;
a CDRL2 amino acid sequence of SEQ ID NO:133 comprising the sequence D-X 6 -S-X 7 -L-X 8 -S, wherein X 6 is F, L, M, or T, X 7 is N or E, and X 8 is A or T; and
a CDRL3 amino acid sequence of SEQ ID NO:134 comprising the sequence X 9 -X 10 -W-S-G-Y-P-Y-T, wherein X 9 is M, C, or S, and X 10 is Q or C;
said heavy chain variable region comprising:
a complementarity determining region heavy chain 1 (CDRH1) amino acid sequence of SEQ ID NO:135 comprising the sequence G-F-X 11 -X 12 -S-X 13 -F-A-X 14 -S, wherein X 11 is T or Q, X 12 is F, S, or T, X 13 is S or P, and X 14 is L or M;
a CDRH2 amino acid sequence of SEQ ID NO:136 comprising the sequence K-X 15 -S-X 16 -G-G-S-X 17 -X 18 -Y-X 19 -X 20 -D-T-X 21 -X 22 -X 23 , wherein X 15 is A or I, X 16 is S or P, X 17 is Y or W, X 18 is T, E, or Y, X 19 is Y or F, X 20 is P, S, D, or F, X 21 is V or D, X 22 is T or A, and X 23 is G or P; and
a CDRH3 amino acid sequence of SEQ ID NO:137 comprising the sequence Q-L-W-G-X24-Y-A-L-D-X 25 , wherein X 24 is S, Y, T, or N, and X 25 is Y, T, F, or I.
2. The pen-injector device of claim 1 , wherein the liquid pharmaceutical formulation comprises acetate buffer, sorbitol, and polysorbate 20.
3. The pen-injector device of claim 2 , wherein the pH of the formulation is about 5.0.
4. The pen-injector device of claim 1 , wherein the pen-injector device is an auto-injector.
5. A pen-injector device containing a liquid pharmaceutical formulation comprising an isolated IL-6 antibody having a complementarity determining region light chain 1 (CDRL1) amino acid sequence of SEQ ID NO:3, a CDRL2 amino acid sequence of SEQ ID NO:21, a CDRL3 amino acid sequence of SEQ ID NO:29, a complementarity determining region heavy chain 1 (CDRH1) amino acid sequence of SEQ ID NO:39, a CDRH2 amino acid sequence of SEQ ID NO:59, and a CDRH3 amino acid sequence of SEQ ID NO:89.
6. The pen-injector device of claim 5 , wherein the liquid pharmaceutical formulation comprises acetate buffer, sorbitol, and polysorbate 20.
7. The pen-injector device of claim 6 , wherein the pH of the formulation is about 5.0.
8. The pen-injector device of claim 5 , wherein the pen-injector device is an auto-injector.
9. A pen-injector device containing a liquid pharmaceutical formulation comprising an isolated IL-6 antibody having a light chain variable region amino acid sequence of SEQ ID NO:97 and a heavy chain variable region amino acid sequence of SEQ ID NO:99.
10. The pen-injector device of claim 9 , wherein the liquid pharmaceutical formulation comprises acetate buffer, sorbitol, and polysorbate 20.
11. The pen-injector device of claim 10 , wherein the pH of the formulation is about 5.0.
12. The pen-injector device of claim 9 , wherein the pen-injector device is an auto-injector.
13. A pen-injector device containing a liquid pharmaceutical formulation comprising an isolated IL-6 antibody having a light chain variable region amino acid sequence of SEQ ID NO:97 and a heavy chain variable region amino acid sequence of SEQ ID NO:99, acetate buffer, sorbitol, and polysorbate 20, wherein the pH is about 5.0 and the pen-injector device is an auto-injector.