Title: Mass spectrometry-based approaches for process optimisation and product quality applications in biomanufacturing
Abstract:
The mass spectrometer (MS) is a versatile instrument suited for the analysis of biomolecules such as proteins, peptides, polysaccharides, small molecules/metabolites and nucleic acids. This presentation describes how MS-based approaches can be utilised for in-depth characterisation of biomanufacturing processes, enabling insights into the nutrient requirements and metabolic behaviour of mammalian cells, which subsequently guide the design of optimal bioprocesses. In addition, we will also describe how MS-based approaches can be applied for quality-control of mRNA therapeutics and other nucleic acid products. These include the qualitative and quantitative assessment of mRNA drug substance modified by capping, poly-A tail and base modifications and the characterization of lipid raw materials used in lipid nanoparticles for mRNA encapsulation. Most recently, we have developed a MS-based analytical workflow that facilitates the structural elucidation of unknown adducts caused by interactions between the mRNA and lipid nanoparticles, with potential downstream impact on mRNA drug product efficacy. These workflows demonstrate the utility of MS-based workflows in addressing challenges in process optimisation and quality-control processes in biomanufacturing.
