Design Of Experiment (DOE) Methodology Effectively Reduces Cost & Time For Analytical Method Development

By Patrick Kellish, Danielle Kling, Richard Smindak, Roger Herr, and Bruce Thompson, Kincell Bio

Robust analytical assays are fundamental to the success of any cell therapy program, supporting every stage from early process development through commercialization and ultimately enabling product release to patients. Reliable assays ensure the accurate, precise assessment of critical quality attributes and process parameters, which is essential for maintaining product consistency, safety, and efficacy. However, the development of complex cell-based assays can be a significant hurdle — often requiring considerable time, resources, and technical expertise — particularly for early-stage innovators with limited capacity.

To address this challenge, Kincell Bio has implemented a Design of Experiment (DoE) approach to streamline and optimize assay development. Unlike traditional one-variable-at-a-time methods, DoE enables simultaneous evaluation of multiple factors within a single study, leading to more efficient use of time, raw materials, and experimental resources.

Using real-world examples — including optimization of an IFN-γ release assay and a flow cytometry-based proliferation assay — we illustrate how DoE can accelerate development timelines, lower costs, and enhance decision-making across cell therapy programs.