Production of biopharmaceuticals is a complex and expensive process that requires extensive monitoring to ensure the product quality. Currently, there are no commercially available process analytical techniques (PAT) capable of in-line/on-line monitoring of critical quality attributes (CQA), such as product concentration and impurities, in production of biopharmaceuticals. Current strategies involve use of UV-VIS to detect total protein concentration in combination with various off-line techniques, including HPLC, MS and ELISA that, for various reasons, are not suitable for in-line/on-line integration.
ArgusEye has developed a functional sensor system that can be used both as an at-line system and/or as an in-line/on-line system in combination with small-scale bioproduction equipment. The system has been designed based on input from bioproduction experts and has primarily been evaluated for detection and quantification of monoclonal antibodies (mAb) using samples from both upstream – and downstream bioprocesses.