CH5240 – Upstream and Downstream Bio-processing
- Introduction: Examples of upstream and downstream operations in biological systems; consideration of different phases of the components; a few typical flow sheet showing arrangements of operations involving wild and modified organisms and the resultant products including temperature resistant and temperature sensitive components; CIP and SIP systems; Facility design process.
- Upstream biological operations: Reactant processing for thermo stable and thermo labile systems; medium formulation involving all phases; medium sterilization – theory and mechanisms, probabilistic and deterministic approaches in the design; Gas sterilization- analysis of collection efficiency from a probabilistic approach, SFE, filter design.
- Downstream biological operations: Arrangements of isolation, recovery, purification, final product formulation; physical separation processes – solid and liquid systems: pretreatment of cells to alleviate mechanical separation processes; disruption of cells including homogenizers, ultrasonic vibrations, pressure, enzymatic etc., kinetics, design and economic consideration; pharmaceutical applications of liquid-liquid extraction; affinity adsorption; rate processes – chromatography; Emerging technologies for cell recovery; separation of intracellular, extracellular, heat and photosensitive materials considering lyophilization; dynamic immobilization, reverse osmosis, electrophoresis, aqueous two-phase systems; electrodialysis, membrane technology; pervaporation, super-critical fluid extractions; case study with design aspect.
- Pharmaceutical packaging operations; Clean room testing and certification and regulatory considerations,validation
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- P.A. Belter E.L. Cussler, W.S. Hu, Bioseparations: downstream processing for biotechnology, John-Wiley, New York, 1988.
- HC Vogel and CM Todaro, Fermentation and Biochemical Eng. Handbook, 3 rd Edn., Elsevier, Amsterdam, 2014