(348e) A Case Study: Utilization of Antibody Purification Platforms - Impact on Timelines

Utilization of platform technologies for antibody purification has been discussed heavily during the last few years. A purification platform can have significant impact on decreasing the timelines in between various stages of the project as well as the technology transfer in between different facilities. In this presentation, we will discuss the use of a first generation purification platform and its application for the purification of a specific antibody. The focus will be on how the platform was tuned for the Preliminary Development process (PDP) and later to support Final Development Process (FDP) and technology transfer to facilities with different capabilities. Examples of purification step modifications (such as operating conditions for chromatography steps to increase productivity and/or impurity clearance, resin reuse) dictated by changes in process stream characteristics and/or facility requirements will be included. In addition, examples of certain efficiencies developed during technology transfer (such as early collaborations between process development and manufacturing colleagues to achieve process fit) and its specific impact to accelerate the timelines will be shared with the audience.