12.08.22 -- Top 2022 Articles On Process Development

Our goal was to establish a host cell line with the desired growth characteristics and capability to seamlessly switch between cloning and production media. Learn how cell performance within the cell line development workflow was confirmed with the successful isolation of stable, high-producing clones from three model monoclonal antibodies.

Bispecific antibodies (bsAbs) have gained increasing interest over recent years because they can bind two antigens, offering unique modes of action compared to monoclonal antibodies. This article describes the further development of a two-step purification of a bsAb.

Digital twins are commonly understood as virtual representations of real-world processes. They can be built using mechanistic or statistical models. Statistical approaches, such as Big Data, machine learning, and artificial intelligence, utilize statistics to predict trends and patterns. Mechanistic models are, instead, based on physical and biochemical principles.

Mechanistic chromatography models are based on mathematical descriptions of the occurring physical and biochemical phenomena in a column. See how fluid flow effects within a chromatography column are used by mechanistic models.

Identifying some key items about your cell line from the beginning, such as the nutrients it needs over the culture time, impact of metabolites, and critical osmolality, can help to rapidly design a simple daily feeding regimen to perform a production scale. This article describes a straightforward way to achieve a high-performing fed-batch process.

In this article, we present an overview of the theory of scaling. Next, we present workflows and strategies and discuss which data are needed for successful scaling. Then, we introduce a scaling tool developed by Cytiva and present several case studies using the tool.