Bacterial host resistance models in the evaluation of immunotoxicity

Cohen, Mitchell D.

doi:10.1016/j.ymeth.2006.08.010

Cited by 9 publications

(2 citation statements)

References 76 publications

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“…This approach is commonly applied for the evaluation of potential immunotoxicity of candidate drugs. 171 By adapting this test to a candidate probiotic strain (e.g., a Lactobacillus) either through direct injection into the tail vein or into the peritoneal cavity, one might overcome the naturally poor infectivity inherent to the Lactobacillus genus. This poor infectivity might be also overcome by immunosuppressing the animals (e.g., with cyclosporine A) 172 prior to using Lactobacillus as the challenge organism.…”

Section: Measurement Of Safety: Limitations Of Existing Modelsmentioning

confidence: 99%

Safety assessment of probiotics for human use

et al. 2010

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The safety of probiotics is tied to their intended use, which includes consideration of potential vulnerability of the consumer or patient, dose and duration of consumption, and both the manner and frequency of administration. Unique to probiotics is that they are alive when administered, and unlike other food or drug ingredients, possess the potential for infectivity or in situ toxin production. Since numerous types of microbes are used as probiotics, safety is also intricately tied to the nature of the specific microbe being used. The presence of transferable antibiotic resistance genes, which comprises a theoretical risk of transfer to a less innocuous member of the gut microbial community, must also be considered. Genetic stability of the probiotic over time, deleterious metabolic activities, and the potential for pathogenicity or toxicogenicity must be assessed depending on the characteristics of the genus and species of the microbe being used. Immunological effects must be considered, especially in certain vulnerable populations, including infants with undeveloped immune function. A few reports about negative probiotic effects have surfaced, the significance of which would be better understood with more complete understanding of the mechanisms of probiotic interaction with the host and colonizing microbes. Use of readily available and low cost genomic sequencing technologies to assure the absence of genes of concern is advisable for candidate probiotic strains. The field of probiotic safety is characterized by the scarcity of studies specifically designed to assess safety contrasted with the long history of safe use of many of these microbes in foods.

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Section: Measurement Of Safety: Limitations Of Existing Modelsmentioning

confidence: 99%

Safety assessment of probiotics for human use

et al. 2010

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“…However, continuous endpoints, e.g., colony/plaque-forming units, are now being used to increase sensitivity. 116 In addition, the susceptibility to infection in animals is dependent both on the degree of immunosuppression and number of challenge organisms. The predictivity of such models for humans, where the degree of immunosuppression may be variable in the out-bred population and the number/ nature of challenge organisms cannot be controlled, is further questioned.…”

Section: In Vivo Studies With Immunomodulatory Mabs-immunotoxicity Asmentioning

confidence: 99%

Safety and immunotoxicity assessment of immunomodulatory monoclonal antibodies

Brennan

Morton

Spindeldreher

et al. 2010

mAbs

212

155

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Abbreviations: ADA, anti-drug antibody; ADCC, antibody-dependent cellular cytotoxicity; ADME, absorption, distribution, metabolism and excretion; APC, antigen-presenting cell; AS, ankylosing spondylitis; CAPS, cropyrin-associated periodic syndromes; CD, cluster of differentiation; CDC, complement-dependent cytotoxicity; CDR, complementarity-determining region; CMV, cytomegalovirus; COPD, chronic obstructive pulmonary disease; CRA, cytokine release assay; CrD, Crohn disease; CRS, cytokine release syndrome; CTLA-4, cytotoxic T lymphocyte antigen-4; DAMPs, damage-associated molecular patterns; DC, dendritic cell; DTH, delayed-type hypersensitivity; EBV, Epstein Barr virus; EFD-PPND, embryo-fetal development and peri-/ post-natal development; EMA, European Medicines Agency; EPAR, European Public Assessment Report; EPO, erythropoietin; ESG, Expert Scientific Group; FDA, Food and Drug Administration; FIH, first-in-human; GD, gestation day; GLP, good laboratory practice; HED, human equivalent dose; HHV-8, human herpes virus-8; HLA, human leukocyte antigen; HSA, human serum albumin; HSP, heat shock protein; HTLV-1, human T cell leukemia virus-1; ICH, International Conference on Harmonization; IHC, immunohistochemistry; KLH, keyhole limpet hemocyanin; LCV, lymphocryptovirus; LFA-1, leukocyte function antigen-1; LPS, lipopolysaccharide; mAb, monoclonal antibody; MABEL, minimum anticipated biological effect level; MHC, major histocompatibility comlex; MoA, mechanism of action; MRSD, maximum recommended starting dose; MS, multiple sclerosis; NCE, new chemical entity; NHP, non-human primate; NK, natural killer; NLR, nod-like receptor; NOAEL, no observed adverse effect level; PAD, pharmacologically-active dose; PAMPs, pathogen-associated molecular patterns; PEG-MGDF, pegylated megakaryocyte growth and development factor; PD, pharmacodynamic; PHA, phytohemaglutinin; PK, pharmacokinetic; PML, progressive multifocal leukoencephalopathy; PsA, psoriatic arthritis; RA, rheumatoid arthritis; RMP, risk management plan; RO, receptor occupancy; RSV, respiratory syncytial virus; SBA, summary basis of approval; SLE, systemic lupus erythromatosus; SPC, summary of product characteristics; SRBC, sheep red blood cell; TCR, tissue cross reactivity; TDAR, T cell-dependent antibody response; TLR, toll-like receptor; TT, tetanus toxoid; UC, ulcerative colitis; VLA-4, very late antigen-4Most therapeutic monoclonal antibodies (mAbs) licensed for human use or in clinical development are indicated for treatment of patients with cancer and inflammatory/autoimmune disease and as such, are designed to directly interact with the immune system. A major hurdle for the development and early clinical investigation of many of these immunomodulatory mAbs is their inherent risk for adverse immune-mediated drug reactions in humans such as infusion reactions, cytokine storms, immunosuppression and autoimmunity. A thorough understanding of the immunopharmacology of a mAb in humans and animals is required to both anticipate the clinical risk of adverse immunotoxic...

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Streptococcus Infection and Immunity

Bradley

2014

Encyclopedia of Immunotoxicology

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Bacterial host resistance models in the evaluation of immunotoxicity

Cited by 9 publications

References 76 publications

Safety assessment of probiotics for human use

Safety assessment of probiotics for human use

Safety and immunotoxicity assessment of immunomodulatory monoclonal antibodies

Streptococcus Infection and Immunity

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