Overview

Our HD-DoE™ (high-dimensional design-of-experiments) technology is a powerful technology platform that can extract conditions for making all types of specialized human cells, including brain neurons, insulin cells, endothelial cells, pigment epithelium, collecting duct cells, and bronchiolar cells to name a few. This is relevant, as it addresses the optimization challenges of cell purity and potency to understand the variance in cell manufacturing methods.

We use computerized DoE, executed through robotic media preparation, to test the entirety of a multidimensional factor space, then we use Multi-Variate Data Analysis (MVDA) to mathematically model the differentiation space and identify effector contributions, interaction terms, and definitions of optimal conditions for reaching specific cell fates.

The Trailhead Bio Difference

Traditional Black-Box Biology

  • Single factor optimization, highly iterative process

  • Experiments designed and limited by the human mind

  • Cell culture is done by hand and prone to error

  • Results are limited to the original design

Trailhead Systems Biology

  • Efficient, multi-dimensional experiments

  • Experiments are designed with mathematical software

  • Robots perform precise, scalable experiments

  • Design enables results to be used in virtual experiments

 

Our HD-DOE™ platform allows us to build protocols for making specialized human cells from iPSCs:

Built from Scratch

Built from Scratch

All protocols are based on unique stage-inducing media, not copied from literature or existing IP

Data, Not Hypothesis, Driven

Data, Not Hypothesis, Driven

All protocols are based on empirical data obtained from using HD-DoE™

 

CPP

CPP

All protocol inputs are statistically qualified as Critical Process Parameters

 

QbD

QbD

All protocols adhere to a Quality-by-Design standard, for all stages

 

Validation

Validation

All protocols are validated through molecular and histological attributes that are respected and qualified by literature

CTAC

CTAC

All protocols are developed to maximize purity, seeking to attain Close-to-Absolute-Conversion to the desired fate

Universality

Universality

Our protocols typically achieve consistent differentiation regardless of iPSC line/clonal origin

Mathematics: Meet Biology

We attain response modeling of key cellular parameters through large dimensioned experiments.

We merge developmental biology and cell therapeutics with cutting-edge hardware, and computerized experimental design and analysis to perform process-specific parameter optimization in order to develop cell therapies. Our HD-DoE™ (high-dimensional design-of-experiments) platform is unique. We are pushing the boundaries of dimensional testing to speak with, and control, biology.

By developing machine-augmented scientific processes, we aim to generate novel data types and structures that are information-dense which can be used to attain control over the cell development process in order to build novel cell therapies.

Specialized Human Cells

HD-DOE™ enables us to develop pure specialized human cells at scale — at a dramatically increased speed, at lower cost, and with less R&D risk