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Clinical Infectious Diseases
Studies from A. Sutton et al provide new data on clinical infectious diseases
April 1st, 2008
According to a study from the United States, "Elements of product and manufacturing-process design are described for product development of live biotherapeutic biological drugs. Product design uses the history and the phenotypic and genotypic characterization of the selected strain." "The quality and integrity of the selected strain can be ensured by preservation in a qualified cell-bank system. Manufacturing-process design includes step-by-step description, including the necessary process-input parameters and the expected output results. The active ingredients in the biological drug are usually manufactured using aseptic processing. The manufacture of the final dosage...
Source: TB & Outbreaks Week (2008-04-01)
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