Trailhead Biosystems merges developmental biology and cell therapeutics with cutting edge hardware, computerized experimental design and analysis to perform process-specific parameter optimization to develop cell therapies. Implementing Quality by Design (QbD) principles, the firm is pioneering the method of High-Dimensional Design of Experiment (DoE), as it seeks to control processes of human cell specialization during industrial culture. Based on mathematical models of the biological system and machine learning, the firm aims to understand the effector-response relationships in cell culture. It then applies systems biology methods of the differentiation space, capturing the fate spread of a stem cell. It can then develop complex, serial recipes for the induction of specialized cells. DoE-based experimental design and robotic execution greatly reduce the number of experiments and time needed for optimizing a large number of variables simultaneously.The firm's methodology starkly contrasts with one-factor-at-a-time, hypothesis-driven research which is inherently biased and limited by the human mind and the human hand. It seeks to implement this methodology to create protocols for any specialized human cell. The firm's R&D focus is in the fields of diabetes, neuronal diseases, blood disorders, and immunotherapies.
