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Biologic drug products: A 5-point strategy for building a robust CMC dossier

Whitepaper

Navigating the path to first-in-human (FIH) trials for biological drug products requires a deep and nuanced understanding of the unique scientific, logistical, and regulatory challenges associated with these large molecule substances. The complexity of biological drugs, including their intricate structures and production processes, demands meticulous attention to regulatory Chemistry, Manufacturing, and Controls (CMC) guidance from the outset. Prioritizing this guidance and thoroughly preparing quality dossiers are crucial to ensuring successful progression through all of the development phases toward commercialization.

The complexities involved in biological drug development, such as ensuring product consistency, purity, potency, and — most, importantly, patient safety — require a strategic approach to regulatory submissions. This report outlines key strategies for crafting a rigorous and thorough CMC dossier, highlighting the importance of early and continuous engagement with regulatory authorities. By identifying and addressing potential issues proactively, sponsors can avoid common deficiencies that often result in clinical holds, thereby facilitating the delivery of much-needed biological therapies while ensuring safe, high-quality products.

Specifically, this whitepaper discusses five strategies for building a robust CMC package to help streamline the path to FIH trials for biologics, including:

  • Include regulatory CMC in early development teams
  • Keep the patient and clinical experience in mind
  • Build a phase-appropriate dossier
  • Consider and convey the basis for strategy
  • Obtain regulatory advice at every opportunity

Download the whitepaper to learn more.

Biologic drug products: A 5-point strategy for building a robust CMC dossier