UpStream, DownStream & Final Formulation
Bioproduction process
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Bioproduction steps
1 - Up Stream Process
Covers every stage of the microorganism's development that take place in the fermentation process : nutrient preparation, cell culture, cell separation, and harvesting.
2 - Down Stream Process
Consists of isolating, purifying, and concentrating the previously produced biological drug substance.
3 - Final Formulation
Procedure that converts a biological drug substance into a formulated drug product thanks to the addition of excipients such as minerals, emulsifiers, polyols but also amino acids.