First, the target is captured by chromatography with Protein A media, and two subsequent polishing steps are then performed according to a variety of protocols, often involving a combination of ion-exchange chromatography and hydrophobic interaction chromatography. Traditionally, MAbs are purified in a three-step process. A large experimental space can be investigated and characterized in a very short timeframe, enabling a better understanding of the effect of process conditions. HTPD uses a screening format to facilitate the identification of optimal experimental conditions by directed, rapid screening of experimental parameters. In this area, a new approach of high throughput process development (HTPD) is emerging as a useful tool for compliance with QbD. This initiative also is applicable to the development of downstream processes in the manufacture of monoclonal antibodies (MAbs). QbD stipulates a better understanding of the influence of raw materials and intermediates, and control of process parameters. The US Food and Drug Administration is also nudging the industry to implement its Quality by Design (QbD) initiative in the manufacturing processes. The use of the 96-well plate format enabled the efficient screening of three different media and optimization of chromatographic parameters to maximize yield at the desired purity level.īiopharmaceutical manufacturers are under increasing pressure to develop and produce biopharmaceuticals cost-effectively and within tight timelines. The most commonly used format for HTPD is the 96-well plate to facilitate rapid screening of chromatographic parameters. This article presents a case study illustrating the benefits of using a high throughput process development (HTPD) approach for choice of media and optimization of the polishing step of a monoclonal antibody in a two-step purification process.
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