Why Developability Matters

White Paper

The Critical Role of Developability in Accelerating Biotherapeutic Successs.

Executive Summary:

In the competitive landscape of biotherapeutic development, the ability to identify and advance drug candidates with a high likelihood of clinical and commercial success is paramount. Poor biophysical properties can derail otherwise promising candidates, leading to costly delays or failures late in development. This white paper examines the value of proactive developability assessments in drug discovery. By identifying biophysical liabilities early using high-throughput methods and minimal material these assessments de-risk portfolios, accelerate development timelines, and enhance success rates without impeding discovery progress.

Why Developability Matters – The High Cost of Poor Developablity

While potency and specificity traditionally dominate the early-stage selection criteria, they don’t tell the full story. Molecules that appear ideal on paper can later struggle with manufacturability, solubility, or stability, leading to reformulations, program delays, or even termination. The challenge is clear: How do we spot risks earlier when screening 10s to 100s of candidates with scarce material before costly optimization begins?

Developability a molecule’s stability, manufacturability, and in vivo performance has emerged as an equally critical factor enabling better informed decisions to guide therapeutic programs from discovery through preclinical development. Early developability assessments prove financially crucial, with industry data revealing late-stage failures often exceeding $500M per program.3 In fact, internal analysis of industry data has shown that developability-screened candidates have 2.5× higher Phase III success rates.

Approach: Developability as a Decision-Driving Framework

At Mosaic Biosciences, we partner with clients to integrate developability profiling early in candidate selection when it delivers the greatest impact. Our approach leverages high-throughput biophysical characterization, analytical development, and deep scientific expertise to uncover critical insights that inform better molecule engineering.

This enables comprehensive, data-driven decision-making, ensuring only the most promising candidates advance. Additionally, our panel of late-stage clinical and FDA-approved antibodies provides a benchmark, allowing us……