Safety Evaluation of mRNA

Seattle Genova offers various technologies that significantly advance the safety evaluation of the mRNA. Seattle Genova believes that the best practice to approach the analytical development of mRNA therapies involves utilizing orthogonal techniques that are ideally sensitive, accurate, and linear over a broad range. Moreover, these methods should be validated appropriately through a relevant phase of clinical development, regulatory submission requirements, or to support ongoing quality control of the approved product.

Seattle Genova WorkFlow

Our workflow comprises multiple steps, which step by step evaluated and analyzed. The safety evaluation proceeded with identifying hazards to mRNA, followed by the hazard check and its quantification. Moreover, once the risk is quantified upon specific criteria and concluded through its safety exclusion.

Seattle Genova Services

Seattle Genova processes their final mRNA product through multiple safety evaluation steps. The steps through which the mRNA passes are cytotoxicity, sensitization, and genotoxicity of the mRNA.

Cytotoxicity of mRNA

Seattle Genova analyses the cytotoxicity of mRNA through the development of multiple disease models, which contributes to complex disease pathways mediated by toxic mRNA molecules. Hence through the toxicity check, the mRNA is safely evaluated and nullifies the possibility of cytotoxicity.  

Sensitization of mRNA

Another essential safety analysis of mRNA is to evaluate for any related sensitization of mRNA to the efficacy of therapeutics. This step plays a critical role in the mRNA vaccine, which demonstrates a higher potential for preventing allergic sensitization by inducing an immunological factor.  

Genotoxicity

Seattle Genova captivates an exact evaluator test for the genotoxicity of mRNA where the component of vaccine and mRNA are liberating from any genotoxic potential.

Deliverables

Seattle Genova believes in the accuracy and integrity of mRNA for protein regulation. For that, we provide precise and accurate services for the appropriate code and expression of mRNA and detailed profiling of each analysis test run on each sample. At the end of each trial, the final product is safely evaluated for related toxicities.