Assay Development Revolutionized: Synthace and Charles River Partner to Tackle Reproducibility Crisis

As artificial intelligence accelerates target discovery and pushes more candidates toward the bench, assay development and transfer have become critical bottlenecks in drug discovery. Teams relying on traditional, one-factor-at-a-time (OFAT) workflows struggle with biological complexity and the field’s widely acknowledged reproducibility problem drains time, resources, and confidence. Against this backdrop, Synthace and Charles River Laboratories (CRL) have announced a collaboration to bring design-of-experiments (DOE), automation, and software into routine assay development and transfer.

The Challenge of Assay Development and Reproducibility

Reproducibility remains a significant challenge in biological research, with approximately 72% of researchers acknowledging a crisis in experimental reproducibility [1]. This issue is estimated to cost the industry $100 billion annually in preclinical research alone [1], [2]. Traditional OFAT methods often fall short in addressing this complexity, leading to delays and variable data.

Introducing High Dimensional Experimentation (HDE)

Synthace CEO and co-founder, Dr. Markus Gershater, champions a next-generation DOE approach called High Dimensional Experimentation (HDE) to compress timelines and improve assay transferability. HDE systematically and simultaneously explores many variables at scale, powered by DOE mathematics, automation, and software. This generates comprehensive datasets that map how factors interact, revealing optimal conditions and potential failure modes earlier in the development process [1].

Unlike OFAT, which varies individual parameters in isolation, HDE allows scientists to explore numerous experimental factors concurrently. By capturing a broader design space in a single run, HDE reduces iteration, strengthens reproducibility, and produces assays that transfer more reliably.

The Synthace and Charles River Collaboration

The collaboration between Synthace and Charles River gives CRL’s discovery clients access to Synthace’s approach for developing, automating, and transferring assays [2]. A proof-of-concept study demonstrated the effectiveness of this partnership: CRL used Synthace to develop a 1536-well assay that explored over 700 conditions. This method was then successfully transferred across different instruments and sites with comparable results [1], [2], [3].

“We’re bringing high-dimensional experiments to hard problems like assay development so teams can test a huge number of conditions in parallel, cut timelines, and really raise quality,” said Dr. Markus Gershater [3].

Impact on Assay Development Timelines

HDE has the potential to significantly compress assay development timelines. Dr. Gershater notes that complex assays, which traditionally take up to nine months to develop, have seen reductions of up to six months in some programs. Simpler biochemical assays can often be developed in a single experiment, taking only days to two weeks, as teams explore the entire design space upfront [1].

Improving Reproducibility and Assay Transfer

Assay transfer often fails due to undocumented, informal choices that influence outcomes. In the CRL proof-of-concept, the team not only reproduced results across different instruments and sites but also discovered that the conventional recipe used previously contained unnecessary reagents, identified as non-contributory by HDE [3].

Synthace’s workflow creates a granular digital record of every step, linking each result to its complete provenance. This detailed experimental map strengthens reproducibility, facilitates method transfer, and supports audits [1].

“You have a fantastically detailed experimental map… for every one of the 1536 wells, you know exactly how that data point was produced,” explained Dr. Gershater [3].

Looking Ahead

Although HDE demonstrates significant benefits in simpler assays, Gershater anticipates the greatest gains will be in cell-based assays and increasingly complex 3D systems and organoids, where multiparameter interactions challenge traditional methods. Charles River plans to standardize HDE across discovery functions to deliver faster, higher-quality outcomes program-wide and connect wet lab designs to AI-driven loops as validation becomes a key bottleneck.

“Biology demands multivariate thinking… my personal hope and ambition is to see this technology enabling progress with ever more sophisticated in vitro systems. That’s where we have an opportunity to lift the ceiling,” concluded Dr. Gershater [1].