CMC Roadmap - Day 1Wednesday, 12 November 2025

Setting the Scene: CMC Studies in the life cycle

• Introduction
• Objectives and outline of course
• Main development stages and regulatory cadre
• The main streams of activity from cell line to drug product
• The CTD for Regulatory filings. Quality Module – overview of main sections
• The importance of CMC : Quality (and Safety and Efficacy)
• Supply
• The pillars of pharmaceutical development
• Criticality Assessment
• Control strategy & Validation
• QBD Principles
• Most relevant regulatory Guidance and where to find it MH

Requirements from Pre-Clinical to Phase 2 CT

• Review of the main streams and initial status
• Broad requirements for Tox and for First in Human Studies
• Cell banking
• Other Raw materials
• Drug Substance Process and Manufacture
• Minimum requirements
• Understanding your process :
• Impurities : identity, clearance, control
• First steps towards a control strategy
• Adventitious contamination and Viral Clearance Studies
• Drug formulation and Drug Product Processing
• Analytical package
• Release methods definition and development
• From method performance to method validation
• In Process Controls (else cover under process?)
• Batch data in the submission
• Product Characterisation and Reference standard
• Stability ( DS and DP)
• Forced degradation studies : necessity and importance
• Why is stability important ?
• Different type of stability studies and typical package for PhI
• Shelf life assignment