28th May 2024
Analytical platform technology is racing to keep pace with the increasing complexity of biologicals. Mass spectrometry (MS) has had a pivotal role in characterisation of conventional biotherapeutics such as monoclonal antibodies, and more recently MS data positively contributed to the improved understanding of products and processes in cell and gene therapy.
Hereby, an overview on the advances in mass spectrometry to improve analytical workflows for regulatory approval of protein biopharmaceuticals will be discussed together with the key role that this technology will play in monitoring the critical quality attributes of cell and gene therapy products and the requirements for innovation in the field.