Roadmap for Drug Product Development and Manufacturing of Biologics

Area of Science:

• Biologics Manufacturing
• Therapeutic Modalities
• Drug Product Development

Background:

• Biologic drug product development involves diverse modalities with unique manufacturing processes.
• Despite differences, commonalities exist in drug product development and manufacturing, including Quality Target Product Profile (QTTP), analytical and formulation development, and regulatory compliance (FDA, EMA, ICH).
• Existing knowledge lacks phase-dependent guidance for drug product development studies from pre-clinical through commercialization.

Purpose of the Study:

• To establish a high-level, phase-dependent roadmap for biologic drug product development and manufacturing.
• To provide a unified framework applicable across different therapeutic modalities.
• To address the gap in specific guidance for aligning studies with clinical development phases.

Main Methods:

• Development of a comprehensive roadmap for drug product development and manufacturing.
• Identification of commonalities and phase-specific requirements across various biologic modalities.
• Integration of regulatory requirements (FDA, EMA, ICH) into the development framework.

Main Results:

• A high-level roadmap for biologic drug product development and manufacturing has been assembled.
• The roadmap provides a unified framework applicable across different therapeutic modalities.
• It delineates studies required in alignment with clinical development phases from pre-clinical to commercialization.

Conclusions:

• A unified roadmap is crucial for efficient biologic drug product development and manufacturing.
• The developed framework supports diverse therapeutic modalities by outlining phase-dependent studies.
• This roadmap aims to guide the industry from early-stage development to commercialization of biologic drug products.