Model ‐assisted process characterization and validation for a continuous two‐column protein A capture process

In this study we introduce three process characterization approaches toward validation of continuous twin ‐column capture chromatography (CaptureSMB), referred to as “standard,” “model assisted,” and “hybrid.” They are all based on a traditional risk‐based approach, using process description, risk analysis, design‐of‐experiments (DoE), and statistical analysis as essential elements. AbstractIn this study we introduce three process characterization approaches toward validation of continuous twin ‐column capture chromatography (CaptureSMB), referred to as “standard,” “model assisted,” and “hybrid.” They are all based on a traditional risk‐based approach, using process description, risk analysis, design‐of‐experiments (DoE), and statistical analysis as essential elements. The first approach, the “standard” approach uses a traditional experimental DoE to explore the design space of the high‐ranked process parameters for the continuous process. Due to the larger number of process parameters in the continuous process, the DoE is extensive and includes a larger num ber of experiments than an equivalent DoE of a single column batch capture process. In the investigated case, many of the operating conditions were practically infeasible, indicating that the design space boundaries had been chosen inappropriately. To reduce experimental burden and at the same time enhance process understanding, an alternative “model assisted” approach was...

Source: Biotechnology and Bioengineering - November 6, 2018 Category: Biomedical Science Authors: Daniel Baur, James Angelo, Srinivas Chollangi, Thomas M üller‐Späth, Xuankuo Xu, Sanchayita Ghose, Zheng Jian Li, Massimo Morbidelli Tags: ARTICLE Source Type: research