mRNA Analytics

Analyzing mRNA samples can be challenging due to the complexity of the Drug Substance intermediates and the final formulated LNP encapsulated Drug Product. These challenges can be even more daunting when trying to manage multiple CDMOs and CROs depending on their areas of expertise. BA Sciences has rolled out a comprehensive array of mRNA analytical services that provide regulatory-tested methodologies for every aspect of characterizing the purity, potency, and identity of mRNA products in a one-stop shop format. BA Sciences strives to provide mRNA analytical services that are tailored to your manufacturing platform. Phase-appropriate qualification strategies are employed and non-cGMP in-process/scale-up optimization services offerings are available. See how we can help!

Accurate characterization of the raw materials utilized in your In Vitro Transcription (IVT) and Lipid Nano Particle (LNP) Drug Product processes is critical to ensuring impure material does not compromise the integrity of your intended formulation. Boston Analytical specializes in cGMP Raw Material testing through both USP and custom-validated methods. Whether you need help with the clinical phase or commercial release raw material testing, BA can provide the solution.

Cold chain stability studies are paramount for the stability evaluation of mRNA and LNP-encapsulated Drug Products. BA has extensive -80°C and -20°C stability capacity and specialized critical assay control for cold chain products and freeze-thaw evaluations. In addition to standard stability storage in cGMP-controlled environments, see below for our stability service management areas of expertise.