On-line characterization in regenerative medicine manufacture.
PhD Supervisor(s): Dr Sourav Ghosh and Prof Nick Medcalf
The published guidance from the regulatory authorities in the US and the EU shows a trend towards on-line and at-line in-process analysis for real-time characterization and control of biomanufacturing process (includes regenerative medicine). Current biomanufacturing practice is limited with respect to technologues and processes with real-time characterization and control at minimal operator dependence that can ensure better product definition, sterility assurance and reproducibility. In order to address this challenge one of the key objectives of the EPSRC Centre for Regenerative Medicine at º¬Ðß²ÝÊÓƵ is to enable such technologies that will enable better regulatory compliance through
a) improved process robustness and
b) approach to the principle of 'real-time testing' (EMEA term) and thereby enhance ease of adoption of the new processes.
Aligned with this objective, the Centre has started a 22 month research project in Nov 2013 in collaboration with Nottingham and Keele. The project, titled "Challenge-led Regenerative Medicine Manufacturing Research", investigates on-line characterization and control in regenerative medicine manufacture with particular focus on the blood exemplar, which is one of the flagship research strands in the Centre. The proposed PhD work will form an intergral part of this strategic research programme and contribute to the work package on identification of parameters, which can define the functional specifications and assure the quality of the manufactured product, and testing the feasibility for on-line characterization of these parameters.
