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Chapter 18 : United States Regulatory Considerations for Development of Live Biotherapeutic Products as Drugs

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United States Regulatory Considerations for Development of Live Biotherapeutic Products as Drugs, Page 1 of 2

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Abstract:

Our expanding knowledge of the nature and importance of the human microbiota has provided additional impetus to investigate the use of beneficial bacteria to promote improved health. Recent technological developments in both next-generation DNA sequencing and novel bioinformatic analyses have advanced our understanding of the nature of our microbiome and the degree to which its makeup correlates with human health and specific disease states. It is clear that the application of these technologies has the potential to inform the mechanisms of beneficial effects and to identify potentially valuable candidates for intervention. It should be noted, however, that there is a long history of the use of bacteria, initially in the form of naturally fermented foods and later by investigation of the potential roles of individual bacterial strains in disease prevention. For example, the strain Nissle 1917 was reportedly isolated about 100 years ago from a World War I soldier who, unlike his cohorts, appeared unaffected by bacterial dysentery, and it has remained a subject of study ever since ( ).

Citation: Dreher-Lesnick S, Stibitz S, Carlson P. 2018. United States Regulatory Considerations for Development of Live Biotherapeutic Products as Drugs, p 409-416. In Britton R, Cani P (ed), Bugs as Drugs. ASM Press, Washington, DC. doi: 10.1128/microbiolspec.BAD-0017-2017
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References

/content/book/10.1128/9781555819705.chap18
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.[CrossRef] [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 : 155156.[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 : 12611280.[CrossRef]
11. Moore T,, Rodriguez A,, Bakken JS . 2014. Fecal microbiota transplantation: a practical update for the infectious disease specialist. Clin Infect Dis 58 : 541545.[CrossRef] [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 : 283288.[CrossRef] [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 : 1316.[PubMed]
14. U.S. Pharmacopeia . 2009. 61. Microbiological examination of nonsterile products: microbial enumeration tests, p S3/43S43/47. 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 S3/47S43/51. 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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