mRNA Vaccine Quality Control

mRNA vaccines constitute a promising alternative to traditional vaccine approaches and have recently gained global attention. This new type of medicine has the potential to revolutionize the ways we treat cancer, infectious diseases, inherited disorders and other diseases, due to its mode of therapy, safety profiles as well as the feasibility of cost-effective and large-scale production. On the other hand, as a relatively new concept, there is a lack of available regulatory guidance to control the vaccine quality. To support and promote mRNA vaccine development, Creative Biogene complies with WHO's guidelines for gene therapy products, providing a series of preclinical testing services to implement the quality control. Our services are comprehensive and customer-orientated, including mRNA vaccine characterization, mRNA vaccine potency testing as well as nonclinical safety and toxicity testing.

Service offering

mRNA vaccine characterization service

The mRNA's quality is critical to guarantee the success of mRNA vaccines (safety, immunogenicity, and efficacy) and should be under strict monitoring. In addition to safety and potency, the vaccine characteristics are quintessential for a successful application. Our professional scientists at our GLP laboratories can test mRNA vaccines and other mRNA-based drugs. We provide the following services (but not limited to)

• Purity and integrity testing
• Sterility testing
• Stability Testing
• Evaluation of particle size, polydispersity, and zeta potential
• Physicochemical tests, such as pH and osmolality
• Delivery system testing

mRNA vaccine potency testing

With the fast development of mRNA vaccines, a specific panel of techniques is needed for potency testing, involving the test of translational efficiency as well as the immunostimulatory properties of mRNA. Here, based on the available state-of-the-art facilities and highly experienced scientists, we strive to offer our customers a turn-key service for mRNA vaccine potency testing, involving in vitro and in vivo methods. Some of our approaches include fluorescence-based assays, enzyme-linked immunosorbent assay (ELISA), and intracellular cytokine staining (ICS).

Nonclinical safety and toxicity testing

Safety/toxicological testing is a regulated and complex process in vaccine development. At the beginning of clinical development, the information provided in these studies is essential and useful, providing parameters for clinical monitoring. However, the monitoring process is complex and lengthy, requiring tremendous investment in time and money. And sometimes unexpected situations might occur to jeopardize the results. We can design testing strategies and offer tailored one-stop services tailored to help customers avoid potential problems. More specifically, our services include

• Single dose toxicity
• Repeated dose toxicity
• Bio-distribution measurement
• Safety pharmacology
• Local tolerance
• Immunogenicity studies

If you are interested in our service, please contact us for more information! We are looking forward to cooperating with you!