CMC Roadmap - Day 2Thursday, 13 November 2025

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

Requirements from Pre-Clinical to Phase 2 CT

• Anticipating the needs on the work streams
• Process Understanding and Design
• Technology Transfer
• Dealing with changes and Comparability

Case Study & Group Exercise

• Gap analyses of the studies available to prepare a Phase 1 submission.
• 4 teams (Analytics, DS, DP, Materials) to cover different parts of case
• 30 – 45 min work in groups : Brief :
• do the existing studies support a Phase 1 file and what are the risks involved?
• Recommendation on eventual additional or superfluous studies
• Map studies / data onto CTD modules (if time)
• 60 min debrief (15 min / group)
• General Conclusions and End of Session