With the rapid development of biotechnology, mRNA vaccines prepared by in vitro RNA synthesis technology have had a huge impact on the prevention of COVID-19 infectious diseases. Many companies, such as Moderna in the United States, CureVac in Germany, and BioNTech in Germany, have developed therapeutic mRNA vaccines and drugs for other diseases such as tumors, infectious diseases, and chronic diseases.
The research and preparation of mRNA vaccines requires a variety of raw materials to ensure the successful development of vaccines. As an innovative leader in the domestic molecular enzyme industry, Yeasen Bio has successfully developed various molecular enzymes through the advanced molecular enzyme two-way technology platform and large-scale protein fermentation and purification technology platform. Products of enzyme-related raw materials. In order to ensure product quality and production capacity, Yeasen Bio has built a GMP-level base in Wuhan to fully meet customers' industrial production needs, with an annual production capacity of more than 5 billion servings.
Raw materials for mRNA vaccine preparation provided by Yeasen
Why Choose Yeasen Biotechnology GMP Grade Products?
At present, Yeasen Biotechnology can provide a complete set of products in the production process of mRNA stock solution. The products are strictly controlled by GMP production and fully meet the requirements of mRNA vaccine production.
Quality Control | Normal level | GMP level |
animal origin | might have | None, a declaration of no animal origin is provided |
Cell bank characterization | Simple | Strict, in line with GMP standards |
Raw material and finished product traceability | Simple | Strict, in line with GMP standards |
Endotoxin Control | none | strict control |
sterile | none | strict control |
Production and inspection lot records | Simple | can provide |
Process Validation Report | none | can provide |
change process | Simple | Strict, in line with GMP standards |
quality system | self built | ISO13485 |
DMF filing | none | Yes (reporting) |
In addition, Yeasen Biotechnology can also provide supporting services such as capping rate detection and system optimization, which have been recognized by the majority of users. For such services, please contact us (Email: overseas@yeasen.com).
Cap rate detection results (LC-MS detection)
Ordering Information
References:
[1] Chaudhary, N., Weissman, D., & Whitehead, K. A. (2021). mRNA vaccines for infectious diseases: principles, delivery and clinical translation. Nature reviews. Drug discovery, 20(11), 817–838.