This presentation summarizes the development and scale-up of a Fab drug conjugate purification process. Process development activities were focused on two main areas: optimization of process modification reactions and identification/assessment of critical raw material attributes, and secondly, the development and optimization of chromatography purification steps. Chromatography resins were selected based on the results of high throughput resin screening experiments of hydrophobic interaction and cation-exchange resins (including a multi-modal resin). The primary function of the first and second chromatography steps is to purify the Fab drug conjugate from process and product related impurities such as un-reacted Fab and higher order Fab drug conjugates and reduce the level of aggregate (since the Fab drug conjugate readily forms aggregates), respectively. Challenges with development and scale-up (bench scale to implementation at pilot scale) for production of Toxicology material will be discussed.

Development and scale-up of a Fab drug conjugate purification process

2019 Spring National Meeting

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.