Dr Amit Katiyar director, Pharma Services Group within Thermo Fisher Scientific on how a new method streamlines the development and quality control of biotherapeutics.
The biopharmaceutical industry requires robust, efficient and reliable analytical methods to demonstrate the safety and efficacy of products during the development and manufacturing of new drugs, in order to safeguard patients. As biotherapeutic molecules become increasingly complex, the methods for analysing them must also evolve. The multi-attribute method (MAM) has emerged as a new approach for analytical characterisation and testing during process development and in quality control (QC) of biopharmaceuticals.
What is MAM?