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U.S. Regulatory Considerations for Development of Live Biotherapeutic Products as Drugs

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  • Authors: Sheila M. Dreher-Lesnick1, Scott Stibitz2, Paul E. Carlson, Jr. Jr.3
  • Editors: Robert Allen Britton4, Patrice D. Cani5
  • VIEW AFFILIATIONS HIDE AFFILIATIONS
    Affiliations: 1: Division of Bacterial, Parasitic, and Allergenic Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993; 2: Division of Bacterial, Parasitic, and Allergenic Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993; 3: Division of Bacterial, Parasitic, and Allergenic Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993; 4: Baylor College of Medicine, Houston, TX 77030; 5: Université catholique de Louvain, Louvain Drug Research Institute, Brussels 1200, Belgium
  • Source: microbiolspec September 2017 vol. 5 no. 5 doi:10.1128/microbiolspec.BAD-0017-2017
  • Received 13 March 2017 Accepted 18 July 2017 Published 29 September 2017
  • Paul E. Carlson, Jr., paul.carlson@fda.hhs.gov
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  • Abstract:

    Interest in the use of bacteria-containing products for the treatment or prevention of disease has increased in recent years. Bacterial preparations for human consumption are commercially available in the form of dietary supplements and typically contain strains with a history of use in food fermentation. Advances in our understanding of the role of the microbiota in health and disease are likely to lead to development of products containing more novel bacterial species, along with genetic modification of strains to provide specific functions. By law, any substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans meets the definition of a drug, and an Investigational New Drug (IND) application for clinical investigation must be filed with the FDA. This article is meant to provide information about the IND submission process and additional considerations with regard to chemistry, manufacturing, and controls information for live biotherapeutic products.

  • Citation: Dreher-Lesnick S, Stibitz S, Carlson, Jr. P. 2017. U.S. Regulatory Considerations for Development of Live Biotherapeutic Products as Drugs. Microbiol Spectrum 5(5):BAD-0017-2017. doi:10.1128/microbiolspec.BAD-0017-2017.

Key Concept Ranking

Bacterial Diseases
0.66454804
Clinical Trials
0.58860546
Genetic Elements
0.5826599
Escherichia coli
0.54545456
Analytical Methods
0.4633323
0.66454804

References

1. Tannock GW. 2002. Probiotics and Prebiotics. Horizon Scientific Press, Wymondham, United Kingdom.
2. Hempel S, Newberry S, Ruelaz A, Wang Z, Miles JNV, Suttorp MJ, Johnsen B, Shanman R, Slusser W, Fu N, Smith A, Roth B, Polak J, Motala A, Perry T, Shekelle PG. 2011. Safety of Probiotics to Reduce Risk and Prevent or Treat Disease. Agency for Healthcare Research and Quality, Rockville, MD.
3. Besselink MGH, Timmerman HM, Buskens E, Nieuwenhuijs VB, Akkermans LMA, Gooszen HG, Dutch Acute Pancreatitis Study Group. 2004. Probiotic prophylaxis in patients with predicted severe acute pancreatitis (PROPATRIA): design and rationale of a double-blind, placebo-controlled randomised multicenter trial [ISRCTN38327949]. BMC Surg 4:12 http://dx.doi.org/10.1186/1471-2482-4-12. [PubMed]
4. Vallabhaneni S, Walker TA, Lockhart SR, Ng D, Chiller T, Melchreit R, Brandt ME, Smith RM, Centers for Disease Control and Prevention (CDC). 2015. Notes from the field: fatal gastrointestinal mucormycosis in a premature infant associated with a contaminated dietary supplement: Connecticut, 2014. MMWR Morb Mortal Wkly Rep 64:155–156. [PubMed]
5. FDA Center for Biologics Evaluation and Research. 2016. Guidance for industry early clinical trials with live biotherapeutic products: chemistry, manufacturing, and control information. http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/General/UCM292704.pdf.
6. U.S. Government Printing Office. 2010. Federal Food, Drug, and Cosmetic Act. In 21—Food and Drugs, 2010 ed; U.S. Government Printing Office: Washington, DC. http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/html/USCODE-2010-title21-chap9-subchapII.htm.
7. FDA. 2013. Investigational New Drug Applications (INDs): Determining Whether Human Research Studies Can Be Conducted Without an IND. https://www.fda.gov/downloads/drugs/guidances/ucm229175.pdf.
8. CBER Office of Communication. 2016. Contacts in the Center for Biologics Evaluation & Research (CBER). https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm106001.htm.
9. FDA. 2009. Guidance for Industry: Formal Meetings between the FDA and Sponsor or Applicants. https://www.fda.gov/downloads/drugs/guidances/ucm153222.pdf.
10. Shapiro SZ. 2002. The HIV/AIDS vaccine researchers’ orientation to the process of preparing a US FDA application for an investigational new drug (IND): what it is all about and how you start by preparing for your pre-IND meeting. Vaccine 20:1261–1280 http://dx.doi.org/10.1016/S0264-410X(01)00453-4.
11. Moore T, Rodriguez A, Bakken JS. 2014. Fecal microbiota transplantation: a practical update for the infectious disease specialist. Clin Infect Dis 58:541–545 http://dx.doi.org/10.1093/cid/cit950. [PubMed]
12. Kelly CR, Kunde SS, Khoruts A. 2014. Guidance on preparing an investigational new drug application for fecal microbiota transplantation studies. Clin Gastroenterol Hepatol 12:283–288 http://dx.doi.org/10.1016/j.cgh.2013.09.060. [PubMed]
13. Ross JJ, Boucher PE, Bhattacharyya SP, Kopecko DJ, Sutkowski EM, Rohan PJ, Chandler DKF, Vaillancourt J. 2008. Considerations in the development of live biotherapeutic products for clinical use. Curr Issues Mol Biol 10:13–16. [PubMed]
14. U.S. Pharmacopeia. 2009. 61. Microbiological examination of nonsterile products: microbial enumeration tests, p S3/43–S43/47. In USP Pharmacists’ Pharmacopeia. U.S. Pharmacopeial Convention, Rockville, MD.
15. U.S. Pharmacopeia. 2009. 62. Microbiological examination of nonsterile products: tests for specified microorganims, p S3/47–S43/51. In USP Pharmacists’ Pharmacopeia, U.S. Pharmacopeial Convention, Rockville, MD.
16. FDA. 2008. Guidance for Industry: CGMP for Phase 1 Investigational Drugs. https://www.fda.gov/downloads/drugs/guidances/ucm070273.pdf [PubMed]
17. FDA CDER. 2003. Guidance for Industry INDs for Phase 2 and Phase 3 Studies Chemistry, Manufacturing, and Controls Information. https://www.fda.gov/downloads/Drugs/Guidances/ucm070567.pdf
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/content/journal/microbiolspec/10.1128/microbiolspec.BAD-0017-2017
2017-09-29
2017-12-13

Abstract:

Interest in the use of bacteria-containing products for the treatment or prevention of disease has increased in recent years. Bacterial preparations for human consumption are commercially available in the form of dietary supplements and typically contain strains with a history of use in food fermentation. Advances in our understanding of the role of the microbiota in health and disease are likely to lead to development of products containing more novel bacterial species, along with genetic modification of strains to provide specific functions. By law, any substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans meets the definition of a drug, and an Investigational New Drug (IND) application for clinical investigation must be filed with the FDA. This article is meant to provide information about the IND submission process and additional considerations with regard to chemistry, manufacturing, and controls information for live biotherapeutic products.

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