Method for effectively removing human immune globulin polymer

[0015] 1. After the FII solution is dealcoholized by ultrafiltration, the protein content of the protein solution is adjusted to 4-7g / L, and the pH value of the solution is adjusted to 5.35-5.55.

[0016] 2. Add 1mol / L sodium octanoate to make the final sodium octanoate content reach 6-8mmol / L, add at a speed of 10-15L / h, stir for more than 4 hours after completion, retest the pH value of the solution to 5.35-5.55, otherwise use pH4.0 Acetate buffer was adjusted to this range. The temperature is controlled at 15-25°C.

[0017] 3. Use 7mmol / L sodium octanoate balance solution (containing sodium octanoate 7mmol / L, sodium chloride: 1.25g / L, pH5.35~5.55, temperature 15℃~25.0℃) 400~600L, add diatomaceous earth 4Kg The upper filter plate of the filter press is cleaned cyclically, and after cleaning, it is pressed and filtered, and the outlet temperature is 10°C to 15°C. After pressing the filter, dry the filter plate with pre-cooled clean air for 30-40 minutes. Wash the filter pl...

[0022] 1. The pasteurized inactivated protein solution was continuously dialyzed with equal volume of water for injection at 2-8°C to a conductivity of 100μs / cm 2 Below, the protein content is concentrated to 10g / L. Adjust the protein content of the protein solution to 4-7g / L, and adjust the pH value of the solution to 5.35-5.55 with pH4.0 acetate buffer or 0.5mol / L sodium hydroxide.

[0023] 2. The following steps are the same as steps 2, 3, and 4 in Example 1.

[0024] step Example 1 No polymer removal step added Polymer content of protein solution after dealcoholization (%) 9.43% 9.43% Polymer content after press filtration (%) 2.73% / Finished polymer content (%) 2.74% 10.11% Yield of human immunoglobulin (g / ㎏FII) 206 219

[0026] Place the sample in an environment of 2-8°C, and measure its multimer data. The measurement method adopts "Chinese Pharmacopoeia" Three Volumes 2010 Edition Appendix VI R Human Immunoglobulin Products Monomer Plus Dimer Determination Method, the results are as follows :

[0027] time sample 1 sample 2 0 month 1.63% 2.74% March 1.62% 2.74% June 1.68% 2.76% September 1.71% 2.80% December 1.77% 2.78% 24 months 1.85% 2.79%

[0028] As can be seen from the measurement of the above-mentioned reserved samples, the product obtained by the method of the present invention has stable sample quality and stable multimer content.