Bioproduction

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Bioproduction is the production of biologics-based therapeutic drugs including protein-based therapeutics, vaccines, gene therapies as well as cell therapies; drugs so complex they can only be made in living systems[1] or indeed are a living system (cell therapies). In practice, ‘bioproduction’ has become loosely synonymous with ‘bioprocessing’ as a way to describe the manufacturing process using, cell culture, chromatography, formulation and related analytical testing for large molecule drugs, vaccines and cellular therapies. Many combinations of reactor types and culture modes are now available for use in bioproduction: e.g., pharming, rocking wave-agitated bag batch, stirred-tank or air-lift fed-batch, and hollow-fiber or spin-filter perfusion. No single production format is inherently superior; that determination depends on many manufacturing capabilities, requirements, and goals.[2] New cell lines, concerns about product quality and safety, emerging biosimilars, worldwide demand for vaccines, and cellular medicine drive new innovative solutions in bioproduction.

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References[edit]

  1. ^ McKown, Robert L. and Coffman, George L., "Development of Biotechnology Curriculum for the Biomanufacturing Industry", Reprinted from Pharmaceutical Engineering, May/June 2002
  2. ^ Whitford, William G., "Archived copy" (PDF). Archived from the original (PDF) on 2011-11-24. Retrieved 2012-02-17.CS1 maint: Archived copy as title (link), Feb-Batch Mammalian Cell Culture in Bioproduction, April 2006