mRNA Vaccine Characterization Services
Messenger RNA (mRNA) vaccines consist of one or more nucleic acids that encode single or multiple vaccine antigen candidates, directly transported into the host cell via customized delivery vectors. In brief, mRNA guides cells to produce a myriad of antigens, and these antigens have the capability to induce potent immune responses. Regulatory guidelines explicitly addressing mRNA vaccines' preclinical evaluation are currently lacking, and the synthetic manufacturing of mRNA is a relatively complex process that may result in impurities. Creative Biogene provides mRNA-based drug R&D services. Based on the general principles as outlined in overarching guidance documents, we provide robust analytical GLP testing to characterize mRNA.
A vaccine's safety, potency, and characteristics are essential for a successful application. As a new generation of vaccines, there is no specific criteria that ensure regulatory compliance and acceptance. In general, the quality attributes of mRNA include purity, integrity, stability, and homogeneity. Our professional scientists can help our customers assess the quality of mRNA and other mRNA-based drugs in our GLP laboratories. Below are some of our assays.
During translation, mRNA purity is crucial for its stability and protein yield, two important factors in a successful mRNA vaccine. We provide high-pressure liquid chromatography (HPLC) and fast protein liquid chromatography (FPLC) to quantify or characterize the mRNA and detect dsRNA, a strongly immunogenic contaminant in in vitro-transcribed (IVT) mRNA synthetic reaction system. We can remove the dsRNA from mRNA vaccines and then detect them by dot blot.
The ability to detect the presence of bacterial endotoxins and viable microorganisms is an important safeguard for vaccine production. We provide sterility testing for mRNA vaccines based on a fully-equipped laboratory and a team of excellent experts. With the help of Creative Biogene, our clients can reduce testing time and accelerate vaccine production.
The stability of vaccines is an essential attribute and plays an important role in follow-up specific applications, such as the distribution and storage of vaccines and vaccination scale. Creative Biogene offers flexible and customer-oriented stability assessment for mRNA vaccine.
- Physicochemical tests, such as pH and osmolality
- Evaluation of particle size, polydispersity, and zeta potential
- Delivery system testing
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. To accelerate vaccine production of our customers, we offer a series of mRNA vaccine characterization services. If you are interested in our service, please contact us or directly send us an inquiry.
- Poveda, C., et al. (2019). "Establishing preferred product characterization for the evaluation of RNA vaccine antigens." Vaccines, 7(4), 131.
- Maruggi, G., et al. (2019). "mRNA as a transformative technology for vaccine development to control infectious diseases." Molecular Therapy, 27(4), 757-772.