Technology Transfer and Scale-up

Development of strategy and approach to streamline scale-up efforts
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
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
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)
Assistance with Facility design
Long-term planning and process feasibility (Project Management)