"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 analytical solution that provides 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 characterization services that are tailored to your mRNA manufacturing platform. Phase-appropriate qualification strategies are employed and non-cGMP in-process/scale-up optimization services offerings are available."
BA Sciences is a cGMP-compliant, FDA/DEA registered, ISO/IEC-17025:2017 accredited analytical laboratory with locations in Salem, NH and Morrisville, NC, providing testing services to Pharmaceutical, Biopharmaceutical & Medical Device companies worldwide. Our focus is to provide undeniably accurate data ensuring patient/consumer safety through critical sampling, staffing, and testing services.
