Downstream Processing in the Biotechnology Industry

• Published in: Molecular biotechnology Vol. 22; no. 1; pp. 87 - 98
• Main Author: Kalyanpur, Manohar
• Format: Journal Article
• Language: English
• Published: Totowa, NJ Humana Press 01.09.2002; Springer Nature B.V
• Subjects: Bacteria; Bacteria - metabolism; Biological and medical sciences; Bioreactors; Biotechnology; Biotechnology - instrumentation; Biotechnology - methods; Biotechnology industry; Cell Fractionation - instrumentation; Cell Fractionation - methods; Cells, Cultured; Centrifugation; Chromatography - instrumentation; Chromatography - methods; Contaminants; Culture media; Fermentation; Filtration - instrumentation; Filtration - methods; Fundamental and applied biological sciences. Psychology; Health. Pharmaceutical industry; Industrial applications and implications. Economical aspects; Membrane filtration; Membranes, Artificial; Production of active biomolecules; Protein Biosynthesis; Proteins - isolation & purification; Quality Control; Studies; Transgenic animals; Vaccins; Recombinant microorganism; Validation; Purification; Ultrafiltration; Adsorption; Centrifuging; Production; Homogenization; Vaccine; Fermentation; Chromatography; Protein
• ISSN: 1073-6085; 1073-6085; 1559-0305
• DOI: 10.1385/MB:22:1:087

The biotechnology industry today employs recombinant bacteria, mammalian cells, and transgenic animals for the production of high-value therapeutic proteins. This article reviews the techniques employed in this industry for the recovery of these products. The methods reviewed extend from the centrifugation and membrane filtration for the initial clarification of crude culture media to the final purification of the products by a variety of membrane-based and chromatographic methods. The subject of process validation including validation of the removal of bacterial and viral contaminants from the final products is also discussed with special reference to the latest regulatory guidelines.