Mammalian versus microbe biologics production an historical perspective. Post-translational modifications including protein folding in biologics and consequences for efficacy. Culture collections and maintenance of cultures.

Origins, storage and applications of continuous cell lines. Aseptic cell culture technique, media and growth requirements for commonly used cell lines including the Chinese Hamster Ovary cell line. Maintenance of a cell bank. Industrial scale chemical based media formulation. Disposal bioreactors, scale up and their operation.

Essential features of a fermenter, different kinds of fermenters, Stirred-Tank Reactors, Bubble Columns Reactors, Airlift Reactors with internal/external draft tubes, Fluidized-Bed reactors. Immobilised cell bioreactors.

Harvest. Separation technologies, centrifugation and filtration, cell disintegration, solvent extraction and other purification techniques.

Batch, Fed batch, Perfusion and Continuous Culture. Metabolic control and the overproduction of desirable metabolites to include primary and secondary metabolites. Issues with scale-up. Fermentation systems, services and ancillary equipment. Fermenter control and instrumentation. Cleaning in place. Sterilization and the maintenance of sterility.

Principles of mass transfer, definition of kLA and its calculation. Respiration of carbohydrates and hydrocarbons. Movement and transfer of oxygen through gas and liquid interface. Critical oxygen level, importance of aeration, agitation and implications of rheology and shear force and shear stress on biocatalysts.

Productivity and Yield Coefficients. Trade off between sterility, power input, aeration and agitation. Addressing the financial viability of an industrial bioprocess, examples from the past present and future perspectives.