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Safety and Toxicology Analysis

Although gene therapy has achieved satisfactory results and been widely applied in preclinical and clinical research, it is also true that in some cases, the gene therapy products themselves may also induce certain toxicity in body, which is caused by the expressed transgene and vectors. At the same time, the off-target effects of gene therapy products may be another related toxic factor. As a frontier biotech service provider, Creative Biolabs now provides safety and toxicology analysis services of gene therapy products for our clients worldwide. Our toxicology studies of gene therapy include the following:

The delivery systems of exogenous gene are usually based on no-viral (e.g. bacteria, polymer and cell carrier) and viral vector (e.g. lentiviral vectors, adenovirus vectors and vaccinia viral vectors). Although some viral carriers have been attenuated by mutations or deletions, the modified virus itself may also infect the human normal system. Creative Biolabs is dedicated to establishing the most exquisite service platform for the vector toxicity study, including the virus replication competence, immunogenicity, persistence, latency, tropism, and the route of administration, etc.

Generally, the transgene toxicity study is depending on the type and property of transgene, such as antibody, immune-modulator gene or microRNA. Creative Biolabs aims to provide customers with services for the transgene toxicity study and we have successfully established the various robust assay methods according to different transgene type. For example, the transgene type is an antibody and our platforms are able to conduct all toxicity related to antibody development. We design assay protocols with customers and select the most appropriate methods to advance your programs.

Off-target toxicity mainly comes from the mutated viral vectors that can still infect normal cells, such as hematopoietic cells, neurons and reproductive system. In some circumstances, the expressed transgene can also generate toxicity in body. Therefore, specific assays need to be developed to analyze the off-target toxicity of transgene and its carriers. With professional service and various technology platforms at Creative Biolabs, we offer the best off-target toxicity assay systems for gene therapy products by utilizing appropriate animal models, designing comprehensive research practices.

Creative Biolabs is able to conduct many indexes to evaluate the safety and toxicity of gene therapy products. Preclinical observations include but are not limited to cytopathic effect (CPE), animal signs, body weight, morbidity and mortality. In addition, pathology studies refer to hematology, coagulation, and urinalysis. Our company also provides the histopathology of the deferent organs, such as heart, liver, spleen, lung, kidney, brain and ovaries, etc.

Creative Biolabs is a remarkable server in the gene therapy filed and offers you world-class safety and toxicology analysis services based on our advanced technology and powerful research & development team. All our experiments are according to FDA guideline and scientists in Creative Biolabs have developed advanced toxicology study system to provide sufficient data for your clinical trials design and optimization. A series of stringent criteria are applied to implement quality control of safety and toxicology analysis to the guarantee reliability. We are pleased to share our precious experience on the gene therapy toxicity evaluation with our clients and please contact us for more detailed information.


  1. Nadine, K. S. & Mark, G. (2018). Safety and Immunogenicity for Gene Therapy Medicinal Products and Therapeutic Vaccines. 27th AGAH Annual Meeting, 26.-27.04.2018, Munich.

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