Downstream processing is the process of bio manufacturing biosynthetic products which starts from natural cells culture such as:
plant and animal tissue and other salvageable components and completing with the best and most appropriate and cleanse product. The processes involved are basically extraction, separation, concentration and purification till the desired final product is attained. In this process, the bioreactor is the major driving component which separates and purifies each unit operation and decides the quality of the finished product from the initial raw materials.
This process is used in large scale production of biological products such as antibiotics, hormones, antibodies and vaccines. These products are nowadays used for medical applications, research and development, pharmaceuticals, genetically modified foods and biotransformation.
The methods and processes implemented in downstream processing highly depend on the temperament and the quality of the raw materials for the production of the required standard product. Depending on the level of purification and whether the product is intracellular or extracellular.
GOALS OF THE DOWNSTREAM PROCESS
Capture and recovery
This is the separation of the desired final product form the natural cells in the bioreactor. This process guarantees high purity of the product.
The objective here is to:
Remove all the micro-particulates.
Separation of the desired product from degradative compounds and proteolytic enzymes
Remove the excess water, growth supplements and other small molecular concentrates in product concentration.
Here the cell is broken by chemical, physical and mechanical method. Any unwanted component is removed through cell separation, which releases the product contained within and captures the recombinant antibodies. In this process, concentration and purification is determined. Only traces (finite) of impurity can be detected if any.
This is the final process that involves the removal of any traces of impurities and contaminants, including not necessary isoforms of the needed therapeutic, inactive and common impurities of other chemical modifications. This process ensures the removal of non-inherent and endogenous viruses in the product and remaining traces of endotoxins, DNA and cell proteins.