Stable aqueous solution composition containing recombinant human anti-PD-1 monoclonal antibody
A monoclonal antibody, PD-1 technology, applied in the field of biomedicine, can solve the problem of poor stability of anti-PD-1 antibody
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Embodiment 1
[0024] Embodiment 1 buffer system screening
[0025] According to the actual application of the buffer system commonly used in monoclonal antibody groups at home and abroad, 20 groups of buffer systems to be investigated were designed. The concentration of the buffer system was 20mM, and the protein content of PD-1 antibody was 30mg / mL. For details, please refer to Table 1. The stock solution was replaced into the following buffer systems, and the thermal stability of the protein in each buffer system was investigated by DSC detection to screen and evaluate each buffer system. The results are shown in Table 1.
[0026] Table 1
[0027]
[0028] Replace the antibody protein into the above 20 buffer systems by changing the liquid. This round of buffer system screening experiment is designed to conduct preliminary screening of 20 buffer systems through DSC detection, and screen out the buffer system with better thermal stability, thereby reducing the second round. Scope of bu...
Embodiment 2
[0036] Embodiment 2 buffer system composition
[0037] Based on the results of the first round of pre-screening in Example 1, 6 groups of buffer systems were selected for this round of screening. The concentration of the buffer system was 20mM, the antibody protein content was 30mg / mL, the temperature was 2-8°C and 40±2°C, and the investigation period was 4 weeks. Please refer to Table 3 for the composition of the buffer system in the second round of screening.
[0038] table 3
[0039]
[0040] The buffer system screening experiment is designed to evaluate and compare 6 groups of alternative buffer systems designed for the present invention by carrying out long-term and 40±2°C high-temperature accelerated stability experiments at 2-8°C. According to its stability, determine the buffer system for subsequent screening of excipients.
[0041] For the summary of the main results of the screening study, see Table 4 Summary of the second round of screening-DSC results, Table 5 S...
Embodiment 3
[0052] The screening of embodiment 3 buffer system and auxiliary material
[0053] Based on the results of the second round of screening of the preparation group—screening of the buffer system, through the investigation under high-temperature accelerated conditions of 2-8°C, 25±2°C and 40±2°C, the four excipients were evaluated from the aspects of maintaining antibody protein stability and adjusting osmotic pressure. Conduct inspections and assessments. The excipients screened in this round include trehalose, sucrose, sodium chloride and mannitol. Except for the sodium chloride group, a certain amount of sodium chloride was added to the excipients in the other three groups to adjust the osmotic pressure concentration to isotonicity. Eight kinds See Table 7 for the composition of alternative preparation groups.
[0054] Table 7
[0055]
[0056] The screening conditions of this round of screening design are 2-8°C, 25±2°C and 40±2°C. During the inspection period, sampling a...
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