Purification method of human-mouse chimeric monoclonal antibody biosimilar
A monoclonal antibody and purification method technology, which is applied in the field of purification of human-mouse chimeric monoclonal antibody biosimilars, can solve the problems of long time consumption, complicated purification process, low recovery rate, etc., and achieve the guarantee of purity and elution steps Simplicity and the effect of increasing the recovery rate
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Embodiment 1
[0073] The technology of the present invention that embodiment 1 laboratory scale load is 25g / L
[0074] The specific operation steps of the purification method adopted in the technology of the present invention are shown in Table 7, and the chromatography method and filler are the same as in Comparative Example 1.
[0075] Table 7 Operation steps
[0076]
[0077] In the above step washing 2, A and B are progressive gradient washing. By adjusting the rotating speed of the two pumps, the B solution is gradually increased to 100% from the initial 0% through 5 column volumes; Initially 100% gradually decreased to 0% over 5 column volumes.
[0078] Table 8 Comparison before and after product purification
[0079]
[0080] Chromatogram see Figure 4 , see Table 8 for quality data. It can be seen from Table 8 that the acidic isomer and basic isomer of the eluted sample are all within the mass range, and the recovery rate is 58%. Compared with Comparative Example 1, on th...
Embodiment 2
[0081] The technology of the present invention that embodiment 2 laboratory scale load is 29g / L
[0082] In this comparative example, except that the load is different from that of Example 1 and no pre-equilibration step is included, the chromatographic method, packing and operation steps are the same as those of Example 1.
[0083] Table 9 Comparison before and after product purification
[0084]
[0085] Chromatogram see Figure 5, see Table 9 for quality data. It can be seen from Table 9 that the acidic isomers and basic isomers of the eluted samples are all within the mass range and the recovery rate is higher than 43% in Comparative Example 2. After purification, the products differ significantly in the composition of the acid-base charge variants. After cationic chromatography, the proportion of acid peak and base peak was significantly reduced, and the proportion of main peak was significantly increased.
Embodiment 3
[0086] The technology of the present invention that embodiment 3 laboratory scale load is 33g / L
[0087] In this comparative example, except that the load is different from that of Example 1, the chromatographic method, packing and operation steps are the same as those of Example 2.
[0088] Table 10 Comparison before and after product purification
[0089]
[0090] Chromatogram see Image 6 , see Table 10 for quality data. It can be seen from Table 10 that the acidic isomers and basic isomers of the eluted samples are all within the mass range and the recovery rate is higher than 40% of Comparative Example 1 and 43% of Comparative Example 2. After purification, the products differ significantly in the composition of the acid-base charge variants. After cationic chromatography, the proportion of acid peak and base peak was significantly reduced, and the proportion of main peak was significantly increased. image 3 Under the prior art laboratory scale, the cation exchang...
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