Immune- and Cell Analytics for Live Biotherapeutic Products

With recent developments in the understanding of the relationship between the microbiota and its host, live biotherapeutic products (LBPs) have shown a great therapeutic potential to prevent or treat diseases. As a leader in novel LBPs development, Creative Biolabs is committed to providing overall solutions for LBPs discovery involving bioanalysis and qualification to evaluate the safety and efficacy of LBPs. Specifically, we perform the immune- and cell analytics to help get authorization before commercialization.

Importance of the Safety Analyses in LBP Development

LBPs applications for promoting the general gut health as well as their potential as biotherapeutics to alleviate certain clinical disorders related to dysbiosis have been revealed in recent decades. However, this “live microorganisms” administration also accompanies with theoretical threats in different at-risk population groups, such as the individuals under neonatal stages and/or those with some clinical conditions including malignancies, leaky gut, diabetes mellitus, and post-organ transplant convalescence. These vulnerable groups often possess weak immunity; thus, some probiotic strains may turn into opportunistic pathogens engendering life-threatening pneumonia, endocarditis, and sepsis. Therefore, it is essential to carefully assess the safety and immunomodulatory effects associated with the deliberate administration of living microorganisms (i.e., probiotics).

Immunomodulation of probiotics. Fig.1 Immunomodulation of probiotics. (Azad, 2018)

Immune- and Cell Analytics Services at Creative Biolabs

Creative Biolabs has extensive expertise in LBP development and analyses. Our specialized techniques and methods are specifically catered to support your LBP analytics needs, such as immune analytics and cell analytics.

  • Immune Analytics Capabilities

    The microbiome plays critical roles in the maintenance of the host’s immune homeostasis through the regulation, stimulation, and modulation of immune responses. And the imbalance in microbiota-immunity interactions is believed to contribute to the pathogenesis of various immune-mediated disorders. To better understand the immunomodulatory effects of probiotics, we have developed an immune analytics platform to investigate the immunomodulatory effects of isolated LBPs.

    • Measuring antibody responses (mucosal IgA response and IgG response)
    • Experimental identification of linear B- and T-cell epitopes
    • Trans-epithelial electrical resistance (TEER) assay
    • Immunomodulatory assay
    • Immunogenicity analysis
    • Screen for neutralizing antibodies
    • Adhesion assay to cultured human cell line to evaluate the ability to modulate the immune system
  • Cell Analytics Capabilities

    Probiotics stimulate different subsets of immune system cells to produce cytokines, which in turn play a role in the induction and regulation of the immune response. Cytokine profiling is an important part of LBPs’ immune cell analytics.

    • Cytokine profiling (antigen-specific IFN-γ, IL-1α, IL-2, IL-4, IL-5, IL-6, IL-10, IL-17, TNF-α) by flow cytometry-based methodology;
    • Oxidative stress evaluation: using human cultured cell lines submitted to induced oxidative damage and evaluating the ability of LBPs to positively impact different biomarkers.

With extensive expertise in the human probiotic field, Creative Biolabs provides a thorough investigation of probiotic strains’ safety, stability, metabolic profiling, antibiotic susceptibility/resistance, potency, etc. If you are interested in our services, please feel free to contact us .

Reference

  1. Azad, M.; et al. Immunomodulatory effects of probiotics on cytokine profiles. BioMed Research International. 2018.

For Research Use Only. Not intended for use in food manufacturing or medical procedures (diagnostics or therapeutics). Do Not Use in Humans.

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