Pandemic outbreaks of infectious diseases, such as the COVID-19 pandemic caused by the SARS-CoV-2 virus, the 2015-2016 Zika virus epidemic in Brazil and American continent, the re-emerging Nipah epidemic in South and Southeast Asia, and the 2013-2016 Ebola virus epidemic in West Africa, pose significant challenges to the healthcare field. A vaccine is a biological agent that is administered (as by injection) to stimulate the body's immune response to a specific infectious agent or disease. It offers hope for ending infectious diseases. However, the development of vaccines using conventional production methods is becoming too slow to effectively respond to new viral outbreaks in the 21st century. Based on this problem, Alfa Chemistry has established a Design of Experiments (DOE) platform to assist in the development of new vaccines.
What is DOE
DOE is a powerful approach to optimizing chemical processes. It is a statistical tool available to engineers that can be used to evaluate single changes or multiple changes to a process at once and predict the resulting change to the output of the process. In simple non-statistical language, DOE allows the maximum amount of information to be obtained from a minimum number of experiments. Save money and time by increasing efficiency. Over the last decade or so, the application of DOE to pharmaceutical process development has greatly increased. With the continuous progress in immunology, DOE is also gradually being used in the development of vaccines.
DOE in vaccine development and its benefits
A large number of vaccine manufacturers are constantly developing new vaccines. With the advent of new vaccines, new or changed processes also follow. In general, process updates are usually accompanied by more or less risk. Product validation testing and prototype production runs are effective, but costly and in many cases, problems are detected late in the development process. Therefore, vaccine manufacturers must use various analytical tools to reduce the risk in vaccine development. They must evaluate every change and how it could affect the outcome of the development. If multiple changes occur at the same time, then the risk doubles. The DOE can be used to evaluate single changes or multiple changes during vaccine development and predict the resulting change to the output of the process. Typically, the benefits of DOE in vaccine development are as follows.
- Improve the success rate of vaccine development and manufacturing.
- Improve the robustness of the vaccine development process and reduce manufacturing deviations and failed/reworked batches.
- Achieve quality objectives for vaccine development and meet quality design requirements.
- Reduce the cost of analytical tests and the overall experimental cycle time.
Why choose us
By utilizing our experienced experts to work with your team, Alfa Chemistry helps you optimize your vaccine development process with a DOE methodology. This will save you cost and time. If you have any questions related to vaccine development, please feel free to contact us. Alfa Chemistry is always your project partner.
Our products and services are for research use only and cannot be used for any clinical purposes.