In Vitro Tools for Live Biotherapeutic Products Assessment

Live biotherapeutics products (LBP) are by nature considered biological medicinal products as the active substances are live microorganisms, which are biological substances. Therefore, LBP must comply with the legislative and regulatory framework for biological medicines. Creative Biolabs has broad and deep knowledge and experience in the LBP field, as well as an advanced technology platform, to develop customized solutions.

How Can the Safety of LBPs be Demonstrated?

For a long time, microbial strains have been considered naturally safe because of their historical use in food. However, when such a strain is the active substance of a pharmaceutical product administered to humans for the prevention or treatment of a disease, safety demonstration in the targeted population is required. Therefore, due to the biological nature of LBPs, preclinical development must be based on the assessment of the risks related to the microorganism(s) and necessitates the use and even the development of suitable and innovative methods and models to assess such risks. Therefore, product developers should engage in preclinical research programs, including in vitro and in vitro models, combinations of organs-on-chips, and artificial organs, all the way up to in vivo models, to illustrate the global safety of their products adapted to specific risks in the intended population.

Toxicology Studies/Safety Assessment

The risk of transfer of antibiotic resistance to other bacteria and the risk of causing the infection are two common risks of LBP. Because the DS of LBP contains viable bacteria, translocation assessment studies are required to demonstrate no bacterial transfer to the systemic circulation to exclude the risk of bacterial infection in patients due to treatment.

In Vitro Research Tools for LBP Assessment at Creative Biolabs

Biological activity can be assessed using in vitro assays to determine which effects of the product may be associated with clinical activity. In the case of LBP, when direct microbial effects on host cells are expected, similar models can provide valuable information on the product MOA. Techniques like organs-on-chip and microfluidic devices containing human cells could accurately reproduce human physiology and the interactions between human cells and bacterial communities.

Organs-on-chip technology is being used to develop cost-effective in vitro models that can more reliably predict the efficacy, toxicity, and pharmacokinetics of the drug in humans, as well as for novel phenotypic screening assays.

Microfluidics provides a high degree of control over cell culture conditions in various aspects. Parallel experimental conditions allow enhanced cell-based screening assays such as immunophenotyping to monitor single-cell cytokine production in response to external stimuli.

Newly developed organoid systems act as a bridge between in vitro and in vivo systems. Organoids are one of the most readily available physiologically relevant models for studying the dynamics of host-microbe interactions in controlled environments. Organoids provide a novel and powerful ex vivo model for studying commensal bacteria, probiotics, and microbiome studies.

Modeling the human body on microfluidic chips.Fig.1 Modeling the human body on microfluidic chips. (Jalili, 2021)

The evaluation of the safety, efficacy and functional properties of probiotics should be conducted through in vitro tests and animal studies. In vitro assays can be used to gain knowledge of probiotic strains and their mechanisms of action. Creative Biolabs has a professional laboratory and first-class technology platform to provide a full range of LBP assessment technical services for biopharmaceutical, biotechnology companies, and research institutions. If you want to learn more detail about our technology, or would like to consult with our experts, please feel free to contact us.

Reference

  1. Jalili, F.S.; et al. Modeling the Human Body on Microfluidic Chips. Trends Biotechnol. 2021, 39: 838-852.

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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