BIEN 670. Downstream Processing .

Introduction to downstream processing (DSP) – principles, characteristics, purpose. Bioprocesses, biomolecules, drug substances, drug products, monoclonal antibodies and Fc fusion proteins, viral vectors, and vaccines. Unit operations - standard practices. Steps and techniques in downstream processing. Harvest and Filtration, Primary capture, Buffer exchange and up-concentration, Purification, Bioconjugation, Formulation. Optimization of downstream processing. Process Analytical Technology (PAT) to support Quality by Design (QbD) in DSP. Regulatory guidelines. Innovative Techniques for Downstream Bioprocessing.