A description of the manufacturing process. Elaborate on each of the following manufacturing stages highlighting quality control activities between open and closed systems. (20 marks): Culturing parameters (e.g. typical batch volume, temperature, agitation speed, nutrient and gas concentrations) Harvesting (e.g. centrifugation force and duration) Purification (e.g. application of bulk feed through column, elution method) Sterile filling (e.g. typical number of resultant doses, dispensing method, excipients added) Container storage (e.g. immediate packaging form, storage conditions)