Biological Safety Test for Live Biotherapeutic Products

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 based on the concept of quality first.

Safety Assessment for Live Biotherapeutic Products

With the progress of live biotherapeutics development, multiple microbiome 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 and who 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 live biotherapeutics products in high-risk populations, such as immunocompromised individuals, deserves special attention.

Biological safety test of probiotic Streptococcus macedonicus strains. Fig.1 Biological safety test of probiotic Streptococcus macedonicus strains. (Tarrah, 2020)

Biological Safety Test of Probiotics in Creative Biolabs

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, 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.

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 not limited to:

For specific services, please feel free to click for detailed information. For safety tests that 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.


  1. Tarrah, A., et al. Genomic and phenotypic assessments of safety and probiotic properties of Streptococcus macedonicus strains of dairy origin. Food Research International. 2020, 130: 108931.

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