The Stability Tests of Vaccines
The vaccine plays an increasingly important role in disease prevention. In recent years, the stability of the vaccine has a big impact on the success of the global immunization program. As part of the effort to ensure the quality of the vaccine, WHO acknowledges the importance of defining clearly defined characteristics of vaccine stability and emphasizes the role of national regulatory authorities in the overall assessment of the vaccine. The purpose of the research on vaccine stability is to prove that vaccine products have acceptable quality, effectiveness and safety for a certain period of time under certain preservation conditions. 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 Stability test of vaccines. We guarantee the finest results for our customers all over the world.
Fig.1 The Engineering Vaccines.
The Type of Vaccine Stability Study
The real-time stability test of vaccines. It is to observe and study the physical, chemical, biological characteristics and change of efficacy of the vaccine over a period of time under the expected conditions of use and preservation. Accelerated stability study is the rate of change in physical, chemical and biological characteristics of a vaccine that is placed at sequence temperature including above the actual preservation temperature. The study provides supporting data on the shelf-life or release criteria for vaccines.
The extreme conditions stability study, is to put the vaccine under extreme environment conditions, such as, light and extreme temperatures. The main purpose is to determine packaging, labeling requirements, shipping, preservation and use considerations and measures to be taken once exposed to extreme conditions. Thermal stability test, it is put vaccine in higher storage temperature after a certain period of time, to observe the main quality standards of compound situation and change ratio, is an important component of the vaccine to approve and release standard. The main purpose is to assess whether a batch of vaccine stable enough and to determine whether a product batch and batch quality uniform.
The Vaccine Stability Study Technology
The methods for determining product shelf life. One is compliance method, that is, a certain index is tested at different time points within a period of time, and the measured value is constantly changing with the passage of time. When the measured value exceeds the specified standard, the maximum shelf life is taken at that time point. Another method is statistical method, that is, a certain index is tested at different time points in a period of time, and finally the results are statistically analyzed, the average value is calculated and the data is analyzed.
The methods for reducing stability variability. One is repeated testing. According to statistics, the variability of repeated 2 tests of a certain method can be 44, and the variability of repeated 6 tests can be reduced to 16. Another method is to use the standard substances in testing. Besides, collecting samples and keeping them under proper temperature while testing, can also reduce stability variability.
Our Strategies to Test the Stability of Vaccines
Fig.2 The evaluation results of vaccine thermal stability.
Our stability test technology is strictly in accordance with WHO's requirements, and the temperature, humidity and experimental facilities in the laboratory are all are world advanced. Creative Biolabs provides not only general vaccine stability assessment, but also stability assessment services for the manufacture and subsequent use of vaccines, such as intermediates and final products. In terms of the design and statistics of stability study, we provide customized services for samples in the study for different purposes. In data analysis, we provide two stability test options: on the basis of "traditional" methods, the acceptance criteria are met and the warranty period is determined within the relevant measurement specifications in the past. For the "new" method, statistical evaluation is used to define a deadline by extrapolating data.
- Fast, accurate results
- High cost performance
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.
