Abstract
The project aims to tackle recombinant protein Quality Control by means of Analytical Quality by Design (AQbD). Recombinant proteins are complex molecules displaying several conformations, post-translational modifications and microheterogeneity which affect efficacy and safety when used as biopharmaceuticals. Liquid chromatography, capillary electrophoresis and mass spectrometry will be applied for evaluation of Critical Quality Attributes (e.g., charge and mass variants) of some monoclonal antibodies (mAbs). Infliximab is selected to establish appropriate validation protocols; in this regard the AQbD is applied providing a rational approach that combines the optimization and validation steps and allows the identification of an optimal zone (the design space) where all possible combinations of method parameters lead to optimal performance. An analytical platform based on the achieved results will be created and applied to a variety of mAbs.
Project details
Unibo Team Leader: Roberto Gotti
Unibo involved Department/s:
Dipartimento di Farmacia e Biotecnologie
Coordinator:
Università degli Studi di FIRENZE(Italy)
Total Unibo Contribution: Euro (EUR) 59.976,00
Project Duration in months: 24
Start Date:
28/09/2023
End Date:
28/02/2026
