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166:, but at different scales of operation and for different purposes. Downstream processing implies manufacture of a purified product fit for a specific use, generally in marketable quantities, while analytical bioseparation refers to purification for the sole purpose of measuring a component or components of a mixture, and may deal with sample sizes as small as a single cell.
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is done to separate those contaminants that resemble the product very closely in physical and chemical properties. Consequently, steps in this stage are expensive to carry out and require sensitive and sophisticated equipment. This stage contributes a significant fraction of the entire downstream
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A widely recognized heuristic for categorizing downstream processing operations divides them into four groups which are applied in order to bring a product from its natural state as a component of a tissue, cell or fermentation broth through progressive improvements in purity and concentration.
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is the removal of those components whose properties vary considerably from that of the desired product. For most products, water is the chief impurity and isolation steps are designed to remove most of it, reducing the volume of material to be handled and concentrating the product.
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and spray drying are typical unit operations. Depending on the product and its intended use, polishing may also include operations to sterilize the product and remove or deactivate trace contaminants which might compromise product safety. Such operations might include the
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205:, and gravity settling. Additional operations such as grinding, homogenization, or leaching, required to recover products from solid sources such as plant and animal tissues, are usually included in this group.
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describes the final processing steps which end with packaging of the product in a form that is stable, easily transportable and convenient.
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is the first step and involves the capture of the product as a solute in a particulate-free liquid, for example the separation of
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Downstream processing and analytical bioseparation both refer to the separation or purification of
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processing expenditure. Examples of operations include affinity, size exclusion, reversed phase
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A few product recovery methods may be considered to combine two or more stages. For example,
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2008) accomplishes removal of insolubles and product isolation in a single step.
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Harrison, Roger G.; Paul W. Todd; Scott R. Rudge; Demetri
Petrides (2003).
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Bioseparations
Engineering: Principles, Practice, and Economics
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Recovery of biosynthetic products from natural sources
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Downstream
Processing-A New Horizone in Biotechnology
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369:. Prentice Hall of India Pvt. Ltd, New Delhi.
285:often isolates and purifies in a single step.
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224:are some of the unit operations involved.
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69:Learn how and when to remove this message
32:This article includes a list of general
348:Bioseparations science and engineering
365:Krishna Prasad, Nooralabettu (2010).
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38:it lacks sufficient corresponding
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310:Validation (drug manufacture)
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295:Fermentation (biochemistry)
237:ion-exchange chromatography
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283:Affinity chromatography
275:expanded bed adsorption
220:, ultrafiltration, and
153:biochemical engineering
53:more precise citations.
203:electro-precipitation
179:Removal of insolubles
143:used in diagnostics;
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82:Downstream processing
228:Product purification
157:chemical engineering
121:human growth hormone
164:biological products
399:Drug manufacturing
394:Chemical processes
300:Separation process
264:removal of viruses
145:industrial enzymes
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247:Product polishing
209:Product isolation
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255:desiccation
109:antibiotics
51:introducing
388:Categories
321:References
218:adsorption
187:filtration
129:infliximab
125:antibodies
59:April 2009
34:references
331:. Wiley.
133:abciximab
289:See also
137:vaccines
113:hormones
214:Solvent
141:enzymes
117:insulin
47:improve
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279:et al.
170:Stages
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127:(e.g.
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