The pharmaceutical journey started with antibiotics and small molecules. This has shifted to large molecules such as antibodies and recently to more complex molecular entities such as next generation protein therapeutics, cell and gene therapies. As we know these newer molecules will revolutionize disease treatment, change the prognosis for many conditions, and help close the undruggable gap. The complexity of these molecules creates analytical challenges beginning at the clone selection stage through process development and commercial production, which has no doubt has already affected you and your team. Obviously COVID has accelerated growth in next-generation vaccines. This growth, and the urgent need for manufacturing of these new therapeutics and vaccines require faster and robust analytics for characterization and impurity analysis of both the molecules such as, bi- & tri-specifics, nucleic acids, oligonucleotides and mRNA, as well as their delivery systems such as viral vectors and lipid nanoparticles.
Over the last decades, capillary electrophoresis (CE), originally used for nucleic acid analysis and plasmid topology, has been successfully deployed to perform validated assays for product characterization and release testing of commercially available protein-based therapeutics. Likewise mass spectrometric based methods (LC-MS) are being increasingly implemented for both small and large molecule characterization and quantitation due to their high levels of precision and specificity. Presented here is a set of CE and LC-MS analytical workflows developed and optimized not just for characterization, quantification of various nucleic acid, viral vectors, LNP and next generation mAb variants, but also for process- and product-related impurities.