Comparability studies of biopharmaceuticals produced by fed-batch or perfusion culture


This project is focussed on upstream bioprocessing and investigates the similarity (identity) of recombinant protein biopharmaceuticals produced in batch culture compared to the same proteins produced in continuous culture. It will involve extensive physico-chemical characterisation using a variety of highly sophisticated analytical techniques. Of specific interest is the extent to which product characteristics can be manipulated using continuous process parameters (i.e. perfusion rate, bleed rate, temperature, pH, and critical media components for quality issues e.g. sugars).12, 13 The project could explore the design envelope for continuous bioprocesses and the potential for these to better meet biosimilar specifications. A successful outcome to this project will be knowledge into the effect of manufacturing process on the molecular identity of the therapeutic protein product, allowing the manufacturer to understand the potential impact of changes to the manufacturing process.

 

Lead investigator Dr Christopher Howard
Associate Investigator Dr Benjamin Schulz
Associate Investigator Prof Stephen Mahler
Postdoc Dr Lucia Zacchi
PhD Student Dinora Roche Recinos
Industry Partner CSL; PIs, Glover, Sandford and Lee (CSL).