Technology Transfer and Validation

Development of strategy and approach to streamline scale-up efforts
Master planning, scheduling and tracking of validation efforts
Project team management
Composing and reviewing scale-up documents, including:
- Pilot scale characterization protocols and reports
- Small scale model protocols and reports
- SOPs, batch records, and related GMP documents
- Process flowcharts
- Commissioning protocols
- Validation Master Plan, protocols, and reports
Development of dimensionless correlations and scaling factors
Troubleshooting differences in process performance at different scales
Risk assessments of process methods, process additives, and leachables/extractables
Gap analysis
CMC section writing and review for global regulatory submissions
Specification development and parameter classification
Technical investigation of deviations and out-of-specification results
Hands-on assistance during engineering runs, commissioning, validation, and other process implementation activities (person in plant)