Raman spectrometer has become the "guardian" of COVID-19 vaccine quality!
With the development of many Chinese vaccines nearing completion, vaccine production and delivery have become a new focus. On December 23, Zhong Nanshan, an academician of the Chinese Academy of Engineering, said that our country's first batch of vaccines will be announced soon.
How safe is the vaccine?
After passing phase I-III clinical trials, China's vaccine has completed more than 1 million doses of emergency vaccination work. The results show that our country's new crown vaccine is very safe and no serious adverse reactions have occurred. When the effect of vaccination is completely certain, it is particularly important to ensure the quality of the vaccine, especially for large-scale production.
The application background of Raman spectroscopy technology:
People have higher and higher requirements for vaccine quality, and the requirements of the pharmaceutical industry are gradually becoming international. In the vaccine production process, the selected excipients will directly affect the quality of the vaccine. In particular, the implementation of my country's new version of GMP has raised the requirements for vaccine manufacturers to a new level. Each batch of raw and auxiliary materials should be identified before the issuance; for the auxiliary materials and intermediate products used in the preparation of finished products, each smallest container should be sampled and identified.
Disadvantages of taking mixed samples for testing:
- Bottles and bottles cannot be tested, there will be missed inspections or uneven samples, which will lead to the risk of contamination of the final product.
- The foreign pharmaceutical industry has long begun to pay attention to the smallest unit of rapid identification and testing of raw and auxiliary materials, while my country is more focused on controlling in accordance with the requirements of the four parts of the Chinese Pharmacopoeia (2015 edition), but these legal identification methods are usually very time-consuming and costly Reagents.
Advantages of Optosky Raman spectroscopy technology:
- No or very little pretreatment of the sample is required. No direct contact with the sample is required, and the sample can be measured directly through the transparent packaging material, which can reduce the risk of contamination of the final product.
- The use environment of the handheld Raman spectrometer is also very flexible. It can be used in the laboratory or directly on the production site. Each sample detection only takes tens of seconds, which can effectively reduce the analysis time and greatly improve the practicability.
Application of Raman spectrometer in inspection of excipients used in vaccine production:
Methods: Raman spectroscopy was used to quickly identify the excipients used in the production of live attenuated Japanese encephalitis vaccine, collect spectra, establish corresponding Raman spectroscopy methods and map libraries, and use these raw and auxiliary materials for verification tests.
The production auxiliary materials tested this time include sucrose, lactose, potassium dihydrogen phosphate, etc. The actual measured results are as follows.
After the rapid identification test of the excipients used in the production of live attenuated Japanese encephalitis vaccine, it is proved that the Raman spectroscopy method can be used to quickly identify the raw materials and the chemical identification of the raw materials can be equivalent to the legal method of the Chinese Pharmacopoeia (2015 edition), or even more. With specificity, it can greatly save laboratory time and cost, and reduce the risk of contamination of the final product.
Raman spectroscopy can provide information about the functional groups in the molecule, which can be used for identification tests and structural analysis. Compare the Raman spectra of the test product and the reference product, and the same compound can be identified as the same compound.
Therefore, the Raman spectroscopy method can be used to analyze the structure of compounds, and can identify raw materials, drug crystal forms, and drug preparations with high accuracy.
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