Abstract
The invention of genetic engineering tools has given birth to a new type of pharmaceuticals known as biopharmaceuticals. These are the drug molecules that have therapeutic effects and are synthesised in biological cell systems. Drug like recombinant insulin is a prominent prototype example of biopharmaceutical which is commonly available in the market at cheap prices for diabetic patients, globally. The production of these therapeutic molecules differs from chemically synthesised low molecular weight drugs. Upstream and downstream processes altogether comprise the production process of biopharmaceuticals. The downstream processing costs 70% of the total production cost of a particular biopharmaceutical, largely contributed by expensive chromatographic techniques such as affinity, hydrophobic interaction, ion exchange and size exclusion. Although chromatography is a reliable and conventional approach to carry out single step purification of biopharmaceuticals, the columns are run in a series to increase the purification fold. This makes the process tedious, and problems like diffusional spreading and resolution are also observed with chromatography procedures. The concern is important as we aim to bring various biopharmaceuticals into market that can treat innumerable diseases at a cheap price.
The current chapter emphasises the process and technology related to the upstream process and the three chronological steps – initial recovery, purification and polishing – involved in downstream processing of biopharmaceuticals. The chapter encompasses the hurdles encountered in the downstream processing in particular with chromatography process that makes high-quality production of biopharmaceuticals an expensive affair thus making it difficult to reach the public. New technologies designed to offer faster and cheaper purification such as aqueous two-phase extraction system, and nano-magnetic-based antibodies separation system have been discussed further. Moreover, we have reviewed and emphasised the requirement of using combination of physical, mathematical, biological and computational approaches, which can help to design efficient production and purification systems for the ample, cheap and continuous market supply of this new category of drugs.
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Mehta, A. (2019). Downstream Processing for Biopharmaceuticals Recovery. In: Arora, D., Sharma, C., Jaglan, S., Lichtfouse, E. (eds) Pharmaceuticals from Microbes. Environmental Chemistry for a Sustainable World, vol 26. Springer, Cham. https://doi.org/10.1007/978-3-030-01881-8_6
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