In order to gain better process and product understanding, manufacturers are increasingly employing Quality by design (QbD) principles during the design and development process. Following the development of a unit operation, process characterization studies are performed to determine acceptable process parameter ranges that ensure critical quality attributes are being met and to define the design space based on the resulting data. For a unit operation with tight parameter ranges and interdependencies, process characterization can be challenging. Several multivariate studies were performed to define an operating space that meet product quality specifications due to the sensitive nature of this bind and elute process to pH, conductivity and temperature. The development, characterization approach and challenges of an ion exchange chromatography step will be discussed.

Development and characterization challenges of an ion exchange chromatography step

249th National Meeting (2015)

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