Clinical Guidelines

A Practical Approach to Early-Phase CMC

Integrated, risk-based chemistry, manufacturing and controls strategies support early-phase development, writes Richard Chubb

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  • February 20, 2026

  • 7 min

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An integrated development approach is essential for a successful CMC section in new drug applications. This method ensures alignment between process development, analytical strategy, formulation, and manufacturing. Emphasizing risk-based decision-making, teams focus on pragmatic, fit-for-purpose solutions rather than technical perfection, enhancing patient safety and product performance. This article delves into Module 3, specifically drug substance (DS) development, outlining key sections and emphasizing early-phase drug characterization and manufacturing strategies, while highlighting the importance of stability studies and regulatory compliance.

Original Source(s)

A Practical Approach to Early-Phase CMC

Integrated, risk-based chemistry, manufacturing and controls strategies support early-phase development, writes Richard Chubb

  • February 20, 2026

  • 7 min

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