Therapeutics & Diagnostics
We are developing scalable manufacturing processes using Quality-by-Design (QbD) approaches undertaking optimisation of bioreactors for AMR therapeutics e.g. bacteriophages, downstream processing for the purification of stable GMP-ready biologicals, and encapsulation unit operations. Working closely in interdisciplinary teams, biologists and process engineers are mapping sources of variability throughout the process e.g. identifying factors leading to batch-to-batch variability in titres, presence of contaminants etc. We are using state-of-the art ‘in-line’ and ‘at-line’ process analytical tools (PAT) to monitor and control the manufacturing process to deliver well-characterised stable biologicals through development of GMP-ready manufacturing platforms.