Adopting Modular, Semi-Automated Approaches To Optimize Process And Analytical Development For Cell & Gene Therapies

By Rubina Pal and Alicia Kramer, Comprehensive Cell Solutions

The complexities inherent in today’s biopharmaceutical development paradigm have necessitated novel approaches for early phase workflows that can accelerate timelines and reduce cost and risk. For both process and analytical development (PD and AD) in the advanced therapy space, this drive toward more automated, closed processing has led to unprecedented innovation aimed at standardizing these workflows to the same degree as other, more incumbent therapeutic modalities.

Yet this pursuit of fully automated, completely closed PD and AD can serve to create new challenges for a workflow – going “all in” on a platform has the potential to introduce inflexibility, limit scalability, and complicate tech transfer. This is largely due to the diversity and complexity of the CGT products in the current development pipeline, which often require customized approaches and bespoke solutions to address the unique variables that accompany their optimization.

There are a number of technology solutions that, when applied to a cell and gene therapy workflow, can streamline development and improve workflow integration. By pursuing targeted automation and modularity for a program, developers can eliminate common workflow bottlenecks, improve manufacturing reproducibility, and establish a highly flexible and controlled development paradigm that can adapt to technical and business considerations.