Overview​

Harnessing nature’s ingenuity opens vast opportunities for biological products. Yet, biochemical engineers often encounter a trade-off: biological complexity brings heterogeneity, which can lead to unforeseen consequences in bioprocesses.

In this webinar, we will explore how heterogeneity critically influences process understanding, robustness, and ultimately product quality. We begin with affinity chromatography, examining the variability within eluates and the questions this raises about product variants.

Next, we delve into host cell protein (HCP) impurities in downstream processing, highlighting surprising mechanisms by which these proteins co-purify and compromise product quality. We then turn to heterogeneity in separation materials, focusing on ligand density variance and its impact on process robustness.

Finally, we explore the behaviour of viral vectors—larger and more complex than therapeutic proteins—during sorption-based separations. This example reveals how such products expand the dimensions we must consider in process development, not only in physical terms but also in the time dimension, as they exhibit heightened sensitivity to residence time in the adsorbed state.

Reflecting on these insights, it becomes clear that process development for new biological products must be equipped to rapidly uncover and understand these critical heterogeneities. Integrating this knowledge into Quality by Design (QbD) frameworks is essential. Consequently, commercial success in this space will be strongly linked to maintaining a workforce skilled in identifying and managing bioprocess heterogeneity.

​Speaker

Daniel Bracewell, Professor of Bioprocess Analysis, Department of Biochemical Engineering, University College London

Daniel is Professor of Bioprocess Analysis at the UCL Department of Biochemical Engineering. His notable contributions have significantly advanced our understanding of biological product purification, often through collaborations with industry leaders. He has authored over 100 peer-reviewed journal articles, many of which involve fruitful partnerships with esteemed institutions in Thailand, India, and the USA.

Currently, he oversees 15 doctoral and postdoctoral projects. One particularly impactful project led to the creation of Puridify, a nanofiber adsorption technology company now owned by Cytiva. As the academic lead for the UCL-Cytiva Centre of Excellence, Daniel is at the forefront of pioneering efforts in bioprocessing. His current focus involves the development of cell-free / enzymatic manufacturing technologies and separations for gene delivery vectors, aimed at facilitating targeted healthcare.

The material presented in this webinar has not been peer-reviewed. Any opinions are the presenters' own and do not necessarily represent those of IChemE or the Biochemical Engineering. The information is given in good faith but without any liability on the part of IChemE.

​​Time

13:00–14:00 BST.

Software 

The presentation will be delivered via Microsoft Teams. We recommend downloading the app from the Microsoft website, rather than using the web
portal.