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Flow type aggregate impurity analyzer

A technology for impurity analysis and aggregates, applied in analytical materials, particle suspension analysis, suspension and porous material analysis, etc. It can solve problems such as sensitivity, resolution or quantitative ability that are difficult to support the formation of standards and regulations, and the inability to achieve particle detection. , to achieve the effect of promoting drug quality control and promoting immunogenicity

Active Publication Date: 2020-08-07
NAT INST OF METROLOGY CHINA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, it is still impossible to detect particles below 200 nanometers, and the sensitivity, resolution or quantitative ability is still difficult to support the formation of standards and regulations

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment approach

[0085] The inventors of the present invention also found that when the sample flow rate is slow, the particle irradiation time is long, and the signal intensity will increase, which is beneficial to the analysis of submicron particles, but not conducive to the analysis of micron particles. Therefore, when detecting submicron particles, it is desirable that the flow rate be as low as possible, and when detecting micron particles, it is desirable that the flow rate is relatively fast. According to a preferred embodiment of the present invention, when the target particle size is any particle size in the range of 0.1-1 μm or any particle size, the flow rate in the center liquid column is controlled to 9-11 μL / min, for example, Can be 9μL / min, 9.2μL / min, 9.4μL / min, 9.6μL / min, 9.8μL / min, 10μL / min, 10.2μL / min, 10.4μL / min, 10.6μL / min, 10.8μL / min, 11 μL / min; when the target particle size is any particle size in the interval above 1 μm or any particle size, the flow rate in the center l...

Embodiment 1

[0192] This example is used to illustrate the method provided by the present invention for detecting the concentration of aggregate particles in a sample under the target particle size

[0193] 1) The assay is described above in " 1. Flow aggregate impurity analyzer ", and select the third type for the setting of "FSC detection channel 22".

[0194] 2) After the sample is filtered, sonicated and pumped in the sample injection unit, the mechanical pump first sucks the sample into the pipeline, and then injects the sample into the sample tube 12 with a peristaltic pump / syringe.

[0195] 3) The sheath fluid is introduced into the sheath fluid tube 11 after being filtered twice by a filter membrane with a pore size of 0.1 μm in the sheath fluid sampling unit.

[0196] 4) The direction of the two liquid flows is from bottom to top when flowing through the flow chamber 13 .

[0197] 5) Obtain the calibration coefficient:

[0198] according to" 3. Detection method In "target pa...

Embodiment 2

[0212] This example is used to illustrate the method provided by the present invention for detecting the concentration of aggregate particles in a sample at the target particle size

[0213]The detection of the concentration of aggregate particles at the target particle size is carried out according to the method of Example 1, the difference is that the setting of "FSC detection channel 22" is selected as the first one.

[0214] The FSC direct channel detector 221 and the FSC side channel detector 225 are independent optical channels. When detecting micron-sized particles, the signal collected by the FSC direct channel detector 221 is mainly analyzed, and the data of the FSC side channel detector 225 is supplemented or not collected; when submicron aggregate particles are detected, the FSC side channel detection is mainly analyzed The signal collected by detector 225, FSC direct channel detector 221 data is supplemented or not collected.

[0215] Since the FSC side channel de...

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Abstract

The invention relates to the field of concentration detection of aggregate particles in medicines, in particular to a flow-type aggregate impurity analyzer. The analyzer comprises a liquid flow system(1), an optical path system (2) and an analysis control system (3), wherein the light path system (2) comprises a laser (21), an FSC detection channel (22) and an SSC detection channel (23), the FSCdetection channel (22) can respectively provide the detection voltage of 405 to 435 V and the detection voltage of 175 to 205 V, and the SSC detection channel (23) is capable of providing a detectionvoltage of 290-310 V and a detection voltage of 120-140 V respectively and providing a threshold of 600-1200. The analyzer disclosed by the invention can be used for simultaneously carrying out the high-sensitivity, high-resolution and accurate quantitative detection on the soluble aggregate particles with the particle sizes of less than 1 micron and more than 200 nanometers and the insoluble aggregate particles with the particle sizes of more than 1 micron in a sample.

Description

technical field [0001] The invention relates to the field of concentration detection of aggregate particles in medicines, in particular to a flow type aggregate impurity analyzer. Background technique [0002] Compared with small molecule drugs, biological products such as recombinant protein drugs, vaccines, human immunoglobulin in blood products, and certain gene therapy carriers, complex injections, and traditional Chinese medicine injections have large molecular weight, complex structure, more modifications, and dynamic changes. Frequent, process control is difficult, and aggregation may occur during production, purification, filling, transportation, and storage, which will affect the quality and immunogenicity of biological products, and further affect the safety and effectiveness of drugs. Since the late 1990s, it has received extensive attention from manufacturing and regulatory authorities. With the development of pharmaceutical technology, the aggregation of produc...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N15/06
CPCG01N15/06G01N15/075
Inventor 胡志上李红梅米薇
Owner NAT INST OF METROLOGY CHINA