Hexameric IgGs are a class of complex biologics that offers unique pharmacokinetics and pharmacodynamic properties due to their high valency (up to 12 antigen binding sites), molecular weight (~900 kDa), or hydrodynamic radius. Despite their attractive profile for certain therapeutic indications, technical challenges in purification and analytics hinder their broader application. This talk aims to demystify some of the challenges by providing comprehensive molecule analysis/illustration and a couple of successful examples where key problems are identified and resolved. It would be of some guidance or introduction for those who are interested in making large and complex biologics for drug discovery and development.

3D printed chromatography columns provide advantages over conventional packed bed resins, in particular, control over the multiscale structure that can be tailored to the needs of the separation. However, possible disparities between design and fabricated columns lessens this benefit. We apply 3D imaging to evaluate and compare printed structures to original CAD files to refine the design process, creating more effective separation capabilities for emergent biological products.

Adequate mixing and buffer exchange during ultrafiltration/diafiltration (UF/DF) are critical for robust downstream bioprocess performance, particularly when mechanical agitation is constrained by equipment or operating limits. In this study, computational fluid dynamics (CFD) modeling was applied to evaluate hydrodynamics, mixing efficiency, and buffer exchange performance in a large-scale UF/DF vessel operated without active agitation during diafiltration.