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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  • 1

    Integrated development approach ensures alignment across manufacturing processes.

  • 2

    Risk-based decision-making is critical in early-phase development.

  • 3

    Module 3 focuses on drug substance and outlines key sections.

  • 4

    Pragmatism in CMC helps manage uncertainties.

  • 5

    Stability studies are essential for justifying API storage conditions.

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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