Manufacturing—
- Cell Culture;
- Fermentation;
- Contamination Reduction;
- Purification;
- Fill Finish;
Aseptic Processing—
Media fills—
Sterility failures—
- Root Cause Analysis and Deviation Resolution;
- Production scale;
Preclinical—
GMP clinical development—
GMP production (commercial/large scale)—
- Process Capability Analysis (CPA);
- Scale-up process;
Process transfer—
Tech transfer—
Commercialization—
- Batch record and SOP drafting and revision.
Facilities—
- Planning;
- Start-up;
- Capital utilization optimization;
- Implementation of multi-product facility operations;
- Evaluation and application of US and European requirements.
Supply chain—
- Raw materials sourcing;
- Warehouse layout and organization;
- Materials management and staging.