The Potency Tests of Vaccines
The correlation between effectiveness testing and clinical efficacy is the basis for vaccine usage. Different methods of testing, like physical chemistry, anti-pathogenicity, immunity, infection, and protection against infection or disease, are used to measure efficacy. Their applicability depends on the nature of the antigen and the purpose of the test. Physical chemistry and antigenic analysis can be used separately or in parallel, in order to control the consistency of production and the vaccine formula, but the correlation between them and the protective effects is often inconclusive. In most cases, the basic immunological characteristics of the antigen and the relationship between these characteristics and the mechanisms of the disease and the mechanism of the immune defense mechanism is very little known. Creative Biolabs is a world leader in the field of vaccine analytical development. With our extensive experience and advanced platform, we are therefore confident in offering the best development services for the potency tests of vaccines. We guarantee the finest results for our customers all over the world.
Fig.1 Neutralizing experiment for HPV Vaccine Potency Test.
The Traditional Vaccine Potency Tests Method
To evaluate the quality of a vaccine, the potency test of the final product must strictly enforce the standards of efficacy established by national regulatory authorities. The universal method for testing the efficacy of vaccines is the animal challenge test. Inoculate the same type of animal with the recommended immunological dose to the prescribe day of age after the optimal immune response period, and attack the immunized animal and the control animal at the same time are capable of causing the animal's pathogenesis, to measure the ability of the vaccine, and to reduce the incidence of the disease after a certain time according to the protection of the immunized animal.
The Alternative Methods of Vaccine Potency Tests
The alternative methods include experimental animal substitution and serological substitution. The first method is to use other animals with similar clinical symptoms to replace the original animals, and indirectly test the efficacy of this animal vaccine. As for serological method, the efficacy of vaccine is assessed by detecting the antibody titer level after immunization. It involves viruses neutralizing experiments and all kinds of ELISA.
Our Strategies to Test the Potency of Vaccines
Our potency test technologies help ensure that each consistently manufactured batch of vaccine which provides a level of protection as determined in the original efficacy study throughout the products shelf life. Creative Biolabs potency test process is often composed of several new technologies and the advantages of the original technology. These assays range from animal challenge test, PD50 test, PGP test, ELISA to PCR. The use of potency control testing is a valuable tool for testing the actual relative strength of manufactured assembly lots of vaccine. Biological-based manufacturing methods are inherently variable and potency testing is a tool to ensure lot-to-lot consistency of commercial vaccines. Our novel test platform provides a rapid, efficient and accurate detection services. We also provide customized services for samples in the study for different purposes.
- High resolution and high cost performance
- High specificity
Creative Biolabs is a leader in the field of vaccine development and has focused on the vaccines analytical development and qualification services for years. We have experienced experts and advanced platforms that are able to provide excellent services. If you are interested in our services, please contact us for more details.
All of our products can only be used for research purposes. These vaccine ingredients CANNOT be used directly on humans or animals.
