Microscopic Counting Method - Detection of Insoluble Particles in Protein Injection

Case study explanation:

The main active ingredients in protein injection are peptide proteins. Compared with small molecule preparations, these drugs have the characteristics of high activity, low toxicity, strong specificity, and are conducive to clinical application, and have a wide range of application prospects.

Due to the special properties of this type of preparation, a certain degree of stress can cause a large number of bubbles to be generated (as shown in Figure 1). When using the photoresist method to detect insoluble particles in this type of preparation, significant false error results will be generated. Therefore, using microscopic counting method for insoluble particle detection in this type of preparation is *.

Sample description: Light milky white liquid with numerous bubbles

Testing process:

Pre processing:Due to the special properties of protein injections, the container bottle cannot be flipped before sample preparation. The container bottle should be rotated to homogenize the sample;

Sample preparation:Open the container bottle, pour it into the filtration device covered with a filter membrane, and perform filtration under low pressure. Place the obtained filter membrane in a petri dish and dry it at low temperature;

Testing:After drying, place the membrane under the lens of YH-MIP 0103 Microscopic Counting Insoluble Particle Analyzer, adjust the parameters, and conduct testing.

Notes:All work is carried out in a clean workbench.

Result analysis:

(b)

(a)

(c)

Figure 2: (a) Global image of the filter membrane, (b) Typical particle image, (c) Test result report

From the full membrane scan image (a) of the sample, it can be seen that the surface of the sample membrane is relatively clean. After testing, the software automatically exports all particle images on the filter membrane. Figure 2 (b) shows some typical particle images on the filter membrane, which has a certain warning effect on the source of insoluble particles in the sample. The test result report (Figure 2c) indicates that the size and quantity of insoluble particles in the sample meet the requirements of the Chinese Pharmacopoeia 2020 edition, and the insoluble particle detection results of the reagent are qualified.

Testing instrument: YH-MIP 0103 Microscopic Counting Insoluble Particle Analyzer

technical advantage

√ Automatic scanning of the entire filter membrane, simple operation, saving time;

√ Fully automatic particle counting, protecting the eyes and reducing human operation errors;

√ Compliant with pharmacopoeias/national standards and regulations of various countries, with one click automatic issuance of corresponding reports;

√ Comply with the requirements of 21CFR Part 11 and GMP for data integrity.

Figure 3: YH-MIP 0103 Microscopic Counting Insoluble Particle Analyzer

Conclusion:From the above discussion, it can be seen that using the YH-MIP series microscopic counting method for insoluble particle analysis of protein preparations has many advantages, mainly reflected in: on the one hand, it can avoid the influence of a large number of bubbles on the detection results; on the other hand, insoluble particles in the sample of protein preparations can be completely retained on the filter membrane, which can be used for subsequent testing and analysis. This has a good guiding role in exploring the aggregation growth kinetics in protein preparations.