Preclinical In Vivo Studies

With professional service and various technology platforms at Creative Biolabs, we can provide one-stop and high-quality in vivo assay services for our customers. Our platform can perform all aspects of gene therapy product's potency tests from the biological characterization to animal tests based on the construction of tumor syngeneic or xenograft models. As a world-leading expert in gene therapy field, various robust animal models and assay systems have been used in-house to greatly facilitate the potency test of gene therapy products with less time and cost. Our experienced scientists are able to help you design the best assays for customized potency test.

Featured Preclinical In Vivo Study Categories

• Xenograft Animal Models

As a leading life science service provider, scientists at Creative Biolabs have successfully established various robust validated animal models covering both hematological malignances and solid tumors, especially in the construction of xenograft animal models. Our professional staffs can perform exquisite tumor xenografting procedures to generate customized animal models, including orthotopical or subcutaneous tumor models and metastasis or disseminated models, etc. Additionally, various tumor cells administration routes can be provided for each particular requirement to set up different tumor models, such as intravenously, subcutaneously or intraperitoneally.

• Products Bio-distribution Test

Typically, the bio-distribution of gene therapy products in vivo mainly relies on the biological characteristics of the carrier. More importantly, the bio-distribution assays are directly related to the gene therapy product's immunogenicity, therapeutic efficacy, off-target effects and mechanism of action (MOA). Scientists in Creative Biolabs have develop efficient platform to analyze the products distribution, target specificity and pharmacodynamics, including the bio-distribution in circulatory system or target organs or major vital organs. To guarantee the high-quality service, experienced technicians on the most appropriate models with the most advanced techniques carry out all tests.

• Products Efficacy Test

Preclinical study of in vivo efficacy provides more powerful data for the later clinical application and guide the clinical trail design, the optimization of administration dose, route and schedule. Our company has established many animal models in-house to perform the efficacy test of gene therapy products, including synergistic and xenograft models. We also develop a comprehensive evaluated system to test the product's efficacy with a special emphasis in the filed of antitumor, such as the parameters of tumor size, weight and in vivo imaging (e.g. bioluminescence imaging & position emission tomography). Of course, the analysis of protein products expression and function in vivo is also in our service area and the commonly used assays techniques (molecular biology, cell biology, histological and pathological analysis) will be applied for the preclinical in vivo studies.

• Products Toxicology Test

Gene therapies have shown promising efficacy in preclinical and clinical studies. However, the introduction of exogenous genes or their carriers may also induce certain toxicity in vivo. In addition, some off-target effects of gene therapy products may also induce toxicity. Creative Biolabs has developed various assays to analyze the toxicity that comes from the vectors and/or the expressed transgene. To support the safety of the proposed clinical application of gene therapy products, specialists in Creative Biolabs have designed a full set of toxicology study systems, including the observations of animal signs and the investigation of pathology.

Highlights

• Various robust animal models (e.g. CDX & PDX model) and assay systems
• Quality control for in vivo assays with GLP-compliant facility
• Individualized services and project design to best fit your program
• Scientists equipped with outstanding expertise and rich experience
• Timely feedback and formal report generation

By utilizing appropriate animal models, designing comprehensive research practices, GLP-compliant and IACUC-regulated facility, Creative Biolabs is able to provide the world-class in vivo validation services for gene therapy development in the process of IND application. Scientists of Creative Biolabs will happy to work with you to design the program and share our rich experience to greatly accelerate your research progress with much lower unpredictable risk. Please do not hesitate to contact us and the technical supporter will get back to you as soon as possible.

Reference

1. De, B.; et al. (2018). In Vivo Potency Assay for Adeno-Associated Virus–Based Gene Therapy Vectors Using AAVrh.10 as an Example. Human Gene Therapy Methods, 29(3), pp.146-155.