William G. Whitford, Sr. Market Manager, Emerging Technologies, Thermo Scientific Cell Culture and BioProcessing & Brandy Sargent, Editor, Cell Culture Dish
"There have been many improvements made in biopharmaceutical manufacturing since its inception in the 1980's. This has culminated in the most common approach to large-scale biopharmaceutical manufacturing being the fed-batch mode applied to suspension culture. Improvements made to the process have involved each of the individual steps, including advances in cloning and selection methods, removal of animal products materials, implementation of single use systems and improved purification resins and columns. This isn't to say that other approaches haven't been tried, even with great success. For example, Genzyme (Sanofi) and Centocor (J&J/Janssen ) have long employed perfusion culture in upstream processes of some approved biopharmaceutical manufacturing. Nevertheless, the overall paradigm of batch-fed process throughout the industry has not evolved a great deal."
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