Speeding Whole Bioprocess Solutions: the Crucial Interface Linking the Bioreactor to Purification

The primary recovery sequence is that which helps link the bioreactor output to the high resolution purification and formulation stages. The operations involved in this sequence are amongst the most challenging for successful predictive design to help take us from the bench to the manufacturing scale. Early decisions taken on the preferred options to be used in the primary recovery stages and predicting how these choices best function together will help us to:-

(a) Determine ways in which to run the bioreactor to help deliver a robust whole bioprocess of an acceptable performance.
(b) Select purification sequences which are robust to variations in feed from the upstream processing stages.

The paper will discuss the integration of available and new ultra scale-down tools for the study at the early stage of process development of different primary recovery options. A range of next generation antibody-related products from both mammalian and bacterial cell hosts will be addressed. These pose challenging bioprocessing problems ranging from high sensitivity to process shear stress through to the need to incorporate selective broth conditioning stages.