Purified antibody composition
The invention provides a method for producing a host cell protein-(HCP) reduced antibody preparation from a mixture comprising an antibody and at least one HCP, comprising an ion exchange separation step wherein the mixture is subjected to a first ion exchange material, such that the HCP-reduced antibody preparation is obtained.
1. A liquid pharmaceutical composition comprising adalimumab and a pharmaceutically acceptable carrier, wherein the adalimumab is expressed in a Chinese hamster ovary (CHO) cell expression system; and the composition is characterized in that when the composition is assayed in a cathepsin L kinetic assay, a level of fluorescent activity no greater than 0.0144 RFU/sec is observed, wherein the cathepsin L kinetic assay comprises:
i. diluting the composition 600-fold in a polystyrene container in a solution containing 25 mM NaOAc, 5 mM DTT and 1 mM EDTA at pH 5.5,
ii. adding dextran sulfate to a concentration of 0.035 μg/mL and incubating at 37° C. for six hours,
iii. adding Z-leucine-arginine covalently bound at its C-terminus to a fluorescent 7-amino-4-methyl coumarin (Z-leucine-arginine-AMC), wherein the diluting, adding, and incubating steps are sufficient to permit the measurement of cathepsin L hydrolysis of the Z-leucine-arginine-AMC within a linear range, and
iv. measuring the fluorescent activity generated by the Z-leucine-arginine-AMC hydrolysis.
2. The liquid pharmaceutical composition of claim 1 , wherein the composition comprises a therapeutically effective amount of adalimumab.
3. The liquid pharmaceutical composition of claim 2 , wherein the composition comprises 20, 40, or 80 mg of adalimumab.
4. The liquid pharmaceutical composition of claim 2 , wherein no detectable level of fluorescent activity is observed.
5. The liquid pharmaceutical composition of claim 2 , wherein the composition is packaged in a pre-filled syringe.
6. The liquid pharmaceutical composition of claim 2 , wherein the composition is suitable for subcutaneous injection.
7. The liquid pharmaceutical composition of claim 2 , wherein no detectable level of fluorescent activity is observed, wherein the composition is packaged in a pre-filled syringe, and wherein the composition is suitable for subcutaneous injection.
8. The liquid pharmaceutical composition of claim 3 , wherein the composition comprises 20 mg of adalimumab.
9. The liquid pharmaceutical composition of claim 8 , wherein no detectable level of fluorescent activity is observed.
10. The liquid pharmaceutical composition of claim 8 , wherein the composition is packaged in a pre-filled syringe.
11. The liquid pharmaceutical composition of claim 8 , wherein the composition is suitable for subcutaneous injection.
12. The liquid pharmaceutical composition of claim 8 , wherein no detectable level of fluorescent activity is observed, wherein the composition is packaged in a pre-filled syringe, and wherein the composition is suitable for subcutaneous injection.
13. The liquid pharmaceutical composition of claim 3 , wherein the composition comprises 40 mg of adalimumab.
14. The liquid pharmaceutical composition of claim 13 , wherein no detectable level of fluorescent activity is observed.
15. The liquid pharmaceutical composition of claim 13 , wherein the composition is packaged in a pre-filled syringe.
16. The liquid pharmaceutical composition of claim 13 , wherein the composition is suitable for subcutaneous injection.
17. The liquid pharmaceutical composition of claim 13 , wherein no detectable level of fluorescent activity is observed, wherein the composition is packaged in a pre-filled syringe, and wherein the composition is suitable for subcutaneous injection.
18. The liquid pharmaceutical composition of claim 3 , wherein the composition comprises 80 mg of adalimumab.
19. The liquid pharmaceutical composition of claim 18 , wherein no detectable level of fluorescent activity is observed.
20. The liquid pharmaceutical composition of claim 18 , wherein the composition is packaged in a pre-filled syringe.
21. The liquid pharmaceutical composition of claim 18 , wherein the composition is suitable for subcutaneous injection.
22. The liquid pharmaceutical composition of claim 18 , wherein no detectable level of fluorescent activity is observed, wherein the composition is packaged in a pre-filled syringe, and wherein the composition is suitable for subcutaneous injection.