Biological Safety Test

Probiotics were once considered "generally safe" and widely used to prevent and treat several diseases. However, with more and more microorganisms that have been identified for disease therapy, there are still many safety risks associated with live biotherapeutic products. Creative Biolabs, a world-renowned service provider for innovative drug discovery, offers custom comprehensive biological safety tests for live biotherapeutic products (LBPs) based on the concept of quality first.

Backgrounds

With the progress of live biotherapeutics development, multiple microbiomes or probiotics have been extensively applied for the prevention and treatment of human diseases and conditions. Currently, an increasing number of preclinical and clinical trials are underway to assess the therapeutic potential and safety of new probiotics, especially those gene-engineered probiotics that do not have a long history of safe use. Probiotic microorganisms are directly orally administrated into the human body to provide a variety of beneficial and therapeutic effects. Some probiotics must be intestinal environmental resistant and antibiotic-resistant to achieve the desired therapeutic effect, which requires high safety to ensure that there will be no potential safety hazard to the body. Furthermore, the safety assessment of LBPs in high-risk populations, such as immunocompromised individuals, deserves special attention.

Fig.1 Biological safety test of probiotic.

The safety assessment of live biotherapeutics products must be comprehensive, not only including general safety testing, but also more importantly should consider the diversity of microorganisms, the health status of hosts, the nature of the specific microbe, the possible interactions between probiotics and other compounds, and so forth. Multiple approaches have been established for the safety assessment of diverse probiotic strains, covering from initial microbe species identification, vitality test, adhesion to host tissues to virulent factor test, and contamination tests, etc.

Biological Safety Test Services

To ensure the safety of every probiotic strain and support the live biotherapeutics drug discovery, Creative Biolabs is working diligently to provide our global customers the maximum support and comprehensive service of biological safety assessment for live biotherapeutic products as much as we can. Our featured safety tests for active probiotics mainly include but are not limited to:

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Case Studies

Objective: This study was to confirm the suitability of the counting method and the Escherichia coli test method according to the USP <61> and USP <62> for the oral solution. Once method suitability was determined, the non-sterile oral solution (Aqueous solution) product bioburden was evaluated (under different storage conditions).

Results: Under different storage conditions on different storage periods, samples of the oral solution passed the acceptance criteria for TAMC, TYMC, and Escherichia coli tests, meeting the USP <1111> Table 1 acceptance criteria for microbiological quality of nonsterile dosage forms of aqueous preparations for oral use under the different storage conditions.

Objective: This study was to evaluate the API's antimicrobial susceptibility profiles using the phenotypic method to confirm whether it inhibits bacterial growth and compared with control antibiotics.

Results: Compared with the control antibiotic, The drug at concentrations did not show any inhibitory effect on the growth of the tested strains, and the MIC values were reported as >2048 mg/L. However, the control could inhibit microbial growth at different low concentrations.

Resources

For specific services, please feel free to click for detailed information. For safety tests that are not found in the above list, please directly contact us. You can also find some tools for live biotherapeutic products safety assessment from us. The experienced scientist team at Creative Biolabs will work with you to provide the most tailored solutions and services.

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