Biopharmaceutical compositions

1. A composition comprising:

a) an anti-IL-5 antibody having a heavy chain amino acid sequence as shown in SEQ ID NO: 1 and a light chain amino acid sequence as shown in SEQ ID NO: 2, and

b) acidic antibody variants of the anti-IL-5 antibody wherein ≤80% of antibodies in the composition are the acidic antibody variants, wherein the acidic antibody variants comprises:

SEQ ID NO: 1, except that residue N386 of Seq ID NO: 1 is deamidated, or

SEQ ID NO: 2, except that residue N31 of Seq ID NO: 2 is deamidated, or a combination thereof.

2. The composition of claim 1 , wherein ≤75% of the antibodies in the composition are the acidic antibody variants.

3. The composition of claim 1 , wherein 20% to 80% or 20% to 45% of the antibodies in the composition are the acidic antibody variants.

4. The composition of claim 1 , wherein 1% to 15% of the antibodies in the composition are basic antibody variants.

5. The composition of claim 1 , wherein residue N31 of Seq ID NO: 2 is deamidated in ≤25% of the antibodies in the composition.

6. The composition of claim 5 , wherein residue N31 of Seq ID NO: 2 is deamidated in: ≤22.5%, ≤20%, ≤17.5%, ≤15%, ≤12.5, ≤10%, or ≤7.5% of the antibodies in the composition.

7. The composition of claim 1 , wherein residue N386 of Seq ID NO: 1 is deamidated in ≤35% of the antibodies in the composition.

8. The composition of claim 1 , wherein residue M64 of Seq ID NO: 1 is oxidized in ≤50% of the antibodies in the composition and residue W52 of Seq ID NO: 1 is oxidized in ≤3% of the antibodies in the composition.

9. The composition of claim 1 , wherein residue M254 of Seq ID NO: 1 is oxidized in ≤50% of the antibodies in the composition, residue M360 of Seq ID NO: 1 is oxidized in ≤50% of the antibodies in the composition, and residue M430 of Seq ID NO: 1 is oxidized in ≤50% of the antibodies in the composition.

10. The composition of claim 1 , wherein ≥50% of the antibodies in the composition comprises SEQ ID NO: 1 except that C-terminal lysine K449 is deleted.

11. The composition of claim 1 , wherein ≥50% of the antibodies in the composition comprises a pyro-glutamate N-terminal.

12. The composition of claim 1 , wherein ≤20% of the antibodies in the composition are aggregated antibody variants.

13. The composition of claim 1 , wherein an antibody variants is measured using capillary isoelectric focusing of the composition.

14. The composition of claim 1 , wherein the antibodies in the composition is at a concentration of between 75 mg/ml and 100 mg/ml.

15. The composition of claim 1 , wherein the composition further comprises:

a) a buffering agent selected from the group consisting of sodium phosphate dibasic heptahydrate, phosphate, citrate, sodium phosphate, potassium phosphate, sodium citrate, and histidine, providing a pH of between 6.8 and 7.2 or a pH of between 6.2 and 6.6;

b) a sugar;

c) polysorbate 80;

d) EDTA; or

e) a combination thereof.

16. The composition of claim 1 , wherein the composition comprises an aqueous liquid formulation comprising:

a) 100 mg/ml antibody;

b) 15.5 mM sodium phosphate dibasic heptahydrate and 4.5 mM citric acid monohydrate at pH 6.3;

c) 12% weight of sucrose to volume;

d) 0.02% weight of polysorbate 80 to volume; and

e) 0.05 mM EDTA.

17. The composition of claim 1 , wherein the composition is lyophilized and comprises:

a) 100 mg/mL antibody;

b) 20 mM sodium phosphate dibasic heptahydrate at pH 6.8 to 7.2;

c) 12% weight of sucrose to volume; and

d) 0.05% weight of polysorbate 80 to volume.

18. The composition of claim 1 , wherein the composition has at least 0.70 IL-5 specific antigen binding activity or at least 70% FcRn binding activity, compared with a reference standard composition, the reference standard composition comprising:

a) an antibody having a heavy chain amino acid sequence as shown in SEQ ID NO: 1 and a light chain amino acid sequence as shown in SEQ ID NO:2;

b) 98% or more heavy chain C-terminal lysine deleted variant;

c) 95% or more heavy chain N-terminal pyroglutamate variant;

d) 6% or less deamidated variant;

e) 4% or less methionine or cysteine oxidated variant;

f) 0.1% or less tryptophan oxidated variant; and

g) 0.4% or less aggregated antibody variant.

19. A pharmaceutical composition comprising the composition of claim 1 , and a pharmaceutically acceptable carrier.