Preclinical study (CMC)

• Process design and screening
• Verification of process parameters, safety and quality attributes
• Preparing of IND filing batch and IND filing support

Clinical stage

• Technical transfer
• Process optimization for COGS, Starting materials and Process Robustness
• Production of clinical API
• Stability study

NDA filing support and commercial

• Kilogram to multi-Ton full scale production
• NDA filing support
• Long-term stability study
• Continuous optimization