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On-demand Webinar

Accelerating Timelines Through Integrated Drug Substance (DS) and Drug Product (DP) Development

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Avoid late-stage surprises. Learn how parallel DS–DP development can recover 2–3 months of timeline and reduce CMC risk.

What you'll learn:

Traditional sequential development often locks in Drug Substance (DS) decisions long before Drug Product (DP) risks are fully understood—leading to formulation failures, costly rework, and extended timelines.

In this on-demand webinar, explore how an integrated DS–DP approach can drive faster, more predictable outcomes. Through a real-world case study, see how synchronized CMC workflows helped recover 2–3 months in development timelines while improving product quality and regulatory readiness.

Key Topics Covered

  • Hidden bottlenecks in traditional small-molecule development
  • Why DS specifications alone don’t ensure DP success
  • Impact of solid-state form, particle attributes, and excipient compatibility
  • Aragen’s “Follow the Molecule” integrated DS–DP approach
  • Case study: Addressing dissolution variability, instability, and content uniformity (CU) challenges through cross-functional CMC integration
  • A 12-month integrated pathway from developability to regulatory submission
  • Particle engineering, formulation optimization, and QbD-aligned development strategies

Why Watch This Webinar

  • Gain insights to accelerate IND timelines by 2–3 months
  • Understand how to proactively mitigate CMC risks
  • Learn how integrated development can improve speed, quality, and decision-making
  • Explore end-to-end small-molecule capabilities under one roof

Speakers

Dr. Srinivasa Rao Madarapu
Dr. Srinivasa Rao Madarapu
Associate Vice President R&D, Chemical Development Solutions
in
Athappan Chidambaram
Athappan Chidambaram
Director R&D, Formulations Solutions
in
Sujatha Anand
Sujatha Anand
Project Manager D&M
in

Frequently Asked Questions

Integrated DS–DP development is a synchronized approach where API development and formulation development progress in parallel rather than sequentially. This allows teams to evaluate solid-state properties, particle characteristics, and formulation compatibility early, reducing development risks and accelerating timelines.

Aragen’s “Follow the Molecule” approach connects discovery, drug substance development, drug product formulation, and manufacturing under one roof. This enables faster decision-making, better risk management, and streamlined progression from developability assessment to regulatory dossier preparation.

Participants will learn how an integrated DS–DP strategy helped resolve key formulation challenges, including dissolution variability, chemical instability, and content uniformity issues. The case study demonstrates how coordinated CMC execution enabled faster development timelines and improved product quality.