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Volume 10
Issue 1-2
10.21775/cimb.010.013
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Current Issues in Molecular Biology is published by MDPI from Volume 43 Issue 1 (2021). Previous articles were published by another publisher in Open Access under a CC-BY (or CC-BY-NC-ND) licence, and they are hosted by MDPI on mdpi.com as a courtesy and upon agreement with Caister Press.
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Review

Considerations in the Development of Live Biotherapeutic Products for Clinical Use

by
Jennifer J. Ross
1,*,
Philip E. Boucher
2,
Siba P. Bhattacharyya
3,
Dennis J. Kopecko
3,
Elizabeth M. Sutkowski
1,
Patricia J. Rohan
1,
Donna K.F. Chandler
1 and
Julienne Vaillancourt
1
1
Division of Vaccines and Related Products Applications, Office of Vaccines Research and Review (OVRR), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA), Rockville, MD, USA
2
Novartis Vaccines and Diagnostics 1, Via Fiorentina, 53100 Siena, Italy
3
Division of Bacterial, Parasitic and Allergenic Products Office of Vaccines Research and Review (OVRR), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA), Rockville, MD, USA
*
Author to whom correspondence should be addressed.
Curr. Issues Mol. Biol. 2008, 10(1-2), 13-16; https://doi.org/10.21775/cimb.010.013
Submission received: 3 January 2008 / Revised: 4 March 2008 / Accepted: 12 April 2008 / Published: 6 June 2008
Versions Notes

Abstract

Food products in the United States (U.S.), including dietary supplements, may contain live microorganisms and can be promoted for general health, nutritional, or structure/function claims. In contrast, such preparations used with the intention of having a preventive or therapeutic effect in humans are regulated by the Food and Drug Administration (FDA) in the U.S. as biological products, specifically as live biotherapeutic products (LBPs). Discussion of considerations in the early development of LBPs may aid in preparation of an Investigational New Drug Application (IND) that is designed to collect clinical data to support marketing approval of a LBP in the U.S. for a specific clinical use. Product information is an important component of an IND to support a proposed clinical study.
Keywords: Food products; microorganisms; general health; nutritional; or structure; function; preventive; therapeutic effect; biological products; live biotherapeutic products Food products; microorganisms; general health; nutritional; or structure; function; preventive; therapeutic effect; biological products; live biotherapeutic products

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MDPI and ACS Style

Ross, J.J.; Boucher, P.E.; Bhattacharyya, S.P.; Kopecko, D.J.; Sutkowski, E.M.; Rohan, P.J.; Chandler, D.K.F.; Vaillancourt, J. Considerations in the Development of Live Biotherapeutic Products for Clinical Use. Curr. Issues Mol. Biol. 2008, 10, 13-16. https://doi.org/10.21775/cimb.010.013

AMA Style

Ross JJ, Boucher PE, Bhattacharyya SP, Kopecko DJ, Sutkowski EM, Rohan PJ, Chandler DKF, Vaillancourt J. Considerations in the Development of Live Biotherapeutic Products for Clinical Use. Current Issues in Molecular Biology. 2008; 10(1-2):13-16. https://doi.org/10.21775/cimb.010.013

Chicago/Turabian Style

Ross, Jennifer J., Philip E. Boucher, Siba P. Bhattacharyya, Dennis J. Kopecko, Elizabeth M. Sutkowski, Patricia J. Rohan, Donna K.F. Chandler, and Julienne Vaillancourt. 2008. "Considerations in the Development of Live Biotherapeutic Products for Clinical Use" Current Issues in Molecular Biology 10, no. 1-2: 13-16. https://doi.org/10.21775/cimb.010.013

APA Style

Ross, J. J., Boucher, P. E., Bhattacharyya, S. P., Kopecko, D. J., Sutkowski, E. M., Rohan, P. J., Chandler, D. K. F., & Vaillancourt, J. (2008). Considerations in the Development of Live Biotherapeutic Products for Clinical Use. Current Issues in Molecular Biology, 10(1-2), 13-16. https://doi.org/10.21775/cimb.010.013

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