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On May 17, 1796, British doctor Edward Jenner successfully inoculated vaccinia for a young boy, making humans begin to master the vaccine technology to fight disease. Vaccines, the biological products made with various pathogenic microorganisms for vaccination, can be divided into two types. The one is the live attenuated vaccine, which include BCG, polio vaccine, measles vaccine, and plague vaccine, and the other is referred to killed vaccine (inactivated vaccine), which mainly include pertussis vaccines, typhoid vaccines, meningococcal vaccines, and cholera vaccines. With the emergence of various vaccines, humans have made great strides in the fight against diseases and use of vaccines has caused many of the most fearful diseases to disappear. However, since the vaccine itself is made from raw material of pathogenic microorganisms, the security risks will be dramatically increased and even bring about life-threatening if the quality does not meet the standard requirements. Therefore, the quality control and quality inspection and analysis of vaccine products are particularly important.
Due to the special nature of vaccines, their use is based on safety and efficacy. Therefore, extensive batch-related quality control is required to ensure the safety and effectiveness of these vaccines. At the same time, most vaccines include, in addition to antigens, some other ingredients, such as adjuvants and protective agents, which affect the quality of the product. These unknown characteristics make each batch of products unique and require strict quality control to ensure the safety and effectiveness of each batch of products. Alfa Chemistry can provide you with a professional analysis of the quality of vaccines.
Antigen content and quality analysis
Antigen is the main active ingredient in the vaccine. By inoculating the pre-treated antigen into the human or animal body, it stimulates the body to produce antibodies, thereby gaining immunity against diseases. Since most antigens are proteins, mature analysis techniques and related instruments such as ultraviolet spectrophotometers, infrared spectrometers, and atomic spectrophotometers can be used for analysis and determination of antigen content and quality in vaccines. In general, the determination of the antigen content requires the use of instruments such as HPLC-MS, GC-MS, and UV spectrophotometers. Combined with our top-notch experts, these advanced techniques and analytical platforms allow Alfa Chemistry to perform the assessment of antigen content and quality timely and accurately.
Physical and chemical properties analysis
The physicochemical properties of vaccines are important basis for the quality of vaccines. These important physical and chemical properties include the pH value of the finished vaccines, osmotic pressure, and the viscosity of solvents. If these physical and chemical properties do not meet the safety standards, inoculation of these problems into the body will lead to serious reactions and even life-threatening. The analysis of physical and chemical properties does not require very complicated techniques and instruments. For example, the pH measurement only requires a pH meter, and the viscosity measurement only requires an ordinary viscometer. Analyzing and measuring these data is simple for Alfa Chemistry .
Other ingredients analysis
In addition to the main component antigens, most vaccines contain some other ingredients, such as adjuvants and protective agents. In addition, the occurrence of toxic and hazardous substances should also be closely monitored. For example, in the testing project for the production of hepatitis B vaccine, in addition to the requirement for the detection of the protein content and the amino acid sequence of the stock solution, it is also required to check the contents of endotoxin, residual antibiotics, and other bacterial microorganisms. In addition to these, the residual amounts of formaldehyde and mercury preservatives need to be monitored. Alfa Chemistry has many advanced instruments including nuclear magnetic resonance spectrometer, ultraviolet spectrophotometer, atomic spectrophotometer, infrared spectrometer and other likes.
Alfa Chemistry has extensive experience in the analysis and testing of various types of vaccines. We have many advanced biochemical analyzers, such as HPLC-MS, GC-MS, protein autoanalyzer, infrared automatic analyzer, UV spectrophotometer, etc. We have a professional analysis team and we will provide you withvaccine analysis services in a timely manner.