Journal Article

Product Development of Probiotics as Biological Drugs

Ann Sutton

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 46, issue Supplement_2, pages S128-S132
Published in print February 2008 | ISSN: 1058-4838
Published online February 2008 | e-ISSN: 1537-6591 | DOI: https://dx.doi.org/10.1086/523325
Product Development of Probiotics as Biological Drugs

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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 form of live bio-therapeutics requires bioburden control or aseptic manufacture, as appropriate. Specifications for live bio-therapeutics must comply with regulations for licensed biological products. Evidence of stability for the duration of the shelf life, as well as stability under the recommended conditions of use, must be provided for licensure.

Journal Article.  3678 words. 

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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