Bioprocessing Strategy—
- Risk Analysis;
- Risk/Benefit Assessments;
- Process Flow Diagrams;
Purification Development/Downstream Processing—
- Protein Purification and Characterization;
- Cell Separation and Sterile Filtration;
- Ultrafiltration and Dafiltration (TFF), Concentration and Buffer Exchange;
- Continuous Centrifugation;
- Two-Phase Liquid-Liquid Extraction;
- Precipitation;
- Aseptic Processing for Cell-Based Therapies;
- Aggregate Reduction.
Disposables—
Buffer preparation—
Chromatography—
- Column Packing;
- Ion Exchange Chromatography;
- Affinity Chromatography;
- Size Exclusion Chromatography;
- Hydrophobic Interaction Chromatography;
- Reversed Phase Chromatography;
- Preparative HPLC.
Product Characterization—
- SDS-PAGE (1D and 2D);
- IEF;
- Capillary Electrophoresis;
- HPLC (RP, IEC and SEC, including Light Scattering Detection);
- Western Blots;
- Aggregate Characterization;
- Residual Host Cell Protein Determination;
- Residual Protein-A Determination;
Formulation development—
Continuous Process Improvement (CIP)—
- Troubleshooting;
- Efficiency;
- Bottleneck Elimination;
- Yield Increase;
- Cost Reduction;
- Gap analysis.
Technical development report writing—