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Preclinical In Vitro Assays Development


With professional service and various advanced equipment at Creative Biolabs, we have established a world-leading platform for the preclinical in vitro assays development of gene therapy products. Our cell-based in vitro assays service focuses on the characterization of products biological property, including the infectivity, cytotoxicity, expression level and function of gene therapy products. Scientists from Creative Biolabs can professionally operate a full range of in vitro assays services that best fit your requirements and the detailed in vitro assays development service are displayed as follows:

Gene therapy products characterization

Throughout the whole history of gene therapy, the major issue to solve is the transportation of exogenous gene into the body and especially into the target cells. Currently, the two most common approaches for gene transfer are viral and non-viral vectors. It is noted that the infectivity and targeting of virus-based delivery system are the key factors of gene therapy products efficacy. At Creative Biolabs, our platforms can provide one-stop service including the cell culture and the evaluation of cell transduction efficiency. Meanwhile, we also offer custom transfection service for our clients.

Generally, it is necessary to consider the effect of exogenous gene introduction and biological properties of the vector on normal cells. Therefore, to accurately measure cytotoxicity of gene therapy products is proven to be a very valuable index in preclinical in vitro validation that might pose certain health risks in patients. Creative Biolabs has established various available assay methods for our clients to measure the cytotoxicity of gene therapy products. In addition, we also introduce some high through and commonly used kits, such as MTT and WST-1 assay.

Typically, the expression level of the protein products coded by transgene defines a significant part of gene therapy products functional activity and their potential to be used in clinical studies. Our company has developed multiple assay approaches for our clients to qualitatively and quantitively analyze the transgene expression, including enzyme-linked immunosorbent assay (ELISA) and/or Western blot and/or qPCR and/or other methods of assessment.

Ideally, the transgene functional assay will represent the product's relevant therapeutic activity or intended biological effect. The transgene type and activity determine what it does. Based on the outstanding expertise and rich experience, Creative Biolabs has the capability to confirm the mechanisms of action (MOA) as assessed by immunochemical (e.g., flow cytometry, ELISA), molecular (e.g., PCR, microarray) or biochemical (e.g., protein binding, enzymatic reactions) methods.

Features of Our Services

Empowered by leading technology and years of experience in gene therapy, our scientists from Creative Biolabs are able to provide the customized, standardized, reliable and high-quality preclinical in vitro assay services for clients all over the world. We are glad to work with you to design the program and support preclinical investigation development of your research. Please contact us and learn more by sending E-mail and our team will get back to you as soon as possible.

For Lab Research Use Only, Not for Human or Animal Therapeutic Use.

Other Potency Tests for Gene Therapy Products:

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