Stability Testing of mRNA Vaccine
As an integral part of the vaccine manufacturing process, stability testing plays a crucial role in the success of immunization programs. Realizing the importance of a vaccine's stability, WHO (World Health Organization) has published guidelines through the various stages and emphasized real-time stability studies that are the basis for determining proposed expiry date, shelf-life, and storage conditions. Creative Biogene is a dedicated provider of the mRNA-based drug R&D service. We are an experienced partner in science and committed to offering integrated solutions for mRNA vaccine development. For stability testing of mRNA vaccine, we have developed systematic protocols, which can be tailored to our clients' timeline, testing needs and budget. Upon request, Creative Biogene can bring transparent and detailed documented data of stability assessment based on the tracking control system.
The stability studies of mRNA vaccine
For mRNA vaccines, the stability evaluation should comply with guidelines for studying the stability of biological products. The stability can reflect the overall quality of vaccines. As for defining the stability profile and indicating parameters, the investigation should take into account the physicochemical property and expression efficiency of mRNA, and supplemented by pH value, appearance, microbial load and so on. The investigation of vaccine stability should be performed under multiple conditions, such as temperature variation, PH change, and light stability.
The stability of vaccines is an essential attribute and plays an important role in follow-up specific applications, involving the distribution and storage of vaccines and vaccination scales. Creative Biogene offers flexible stability testing for mRNA vaccines following WHO's guidelines.
To thoroughly investigate mRNA vaccine's stability, we need to follow a series of parameters that indicate the changes in vaccine quality. Please see the figure below for the specific parameters. For the study design and data analysis, apart from stability-indicating parameters, the time points are discussed. In addition, to define storage conditions, storage methods and relevant research for vaccine production, we have developed different testing strategies according to the needs of the individual project. Our strategies can be generally divided into two categories: testing under extreme conditions or intended storage conditions, involving multiple condition factors, including the temperature variation, light stability, humidity, multigelation as well as PH change.
The stability indicating parameters of mRNA vaccine
Creative Biogene is passionate about strong customer orientation and high-quality service. We continuously challenge ourselves to remain one of the leading service providers in the field of mRNA-based drug R&D worldwide. With the help of Creative Biogene, our clients can obtain the advantages of eliminating bottlenecks, decreasing testing time as well as accelerating vaccine production. Moreover, our clients have direct access to our staff to keep track of the progress of their projects. If you would like more information about our stability testing capabilities, please contact us or directly send us an inquiry.
- Schofield, T. L. (2009). "Vaccine stability study design and analysis to support product licensure." Biologicals, 37(6), 387-396.