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Potency Tests for Gene Therapy Products


As a world-renowned service provider for gene therapy, Creative Biolabs not only offerings a variety of gene therapy products, but also provides the potency tests for the products to our clients all over the world. For gene therapy products, it is necessary to collect sufficient product characterization data for the clinical development including the preclinical in vitro assays of transgene expression and in vivo validation of protein products function based on the syngeneic or xenograft tumor models. Based on advanced technology and years of research, our customizable potency tests services can be designed to best suit your program requirements and greatly assist your research.

Preclinical In vitro assays development

Generally, gene therapy products used in clinical studies depend on the cell‐based in vitro evaluation of the products to generate the therapeutic protein coded by the transgene. Unlike traditional drugs, the potency tests for a gene therapeutic involve the measures of multiple steps, such as the infectivity of the carrier, the transcription and translation of transgene, and the modifications and function of the protein products, etc. At Creative Biolabs, our scientists will professionally perform multiple in vitro assays to verify the potency of gene therapy products. Typically, the commonly used methods include western blot (WB), enzyme-linked immunosorbent assay (ELISA), and flow cytometry (FCM), etc.

Preclinical In vivo studies

The development of gene therapy product requires rigorous in vivo studies and quality control to assure drug potency. In Creative Biolabs, we have established a most exquisite service platform for the in vivo validation that separately evaluates infection, transcription and resulting protein levels, proper localization and therapeutic efficacy of the protein products on the appropriate models with the most advanced techniques. Both human and murine disease model can be built to validate the potency of drugs in immuno-competent or immuno-compromised mouse models or even non-human primate models. In addition, we are also able to perform the potency assays in a GLP-compliant and IACUC-regulated facility to help our customers to expedite their Investigational New Drug (IND) application or Biologics License Application (BLA).

Creative Biolabs is dedicated to providing high-quality potency tests of gene therapy products to our clients all over the world. Our custom services cover the entire gene therapy development process and the evaluation assays either in vitro or in vivo allowing our clients to design according to their targets and downstream applications. As a frontier biotech service provider, we possess outstanding expertise and rich experience in the filed of gene therapy and promise to provide every client with our intimate service and ideal results, especially timely and accurate feedback of project progress. We are glad to share our valuable experience to help your research and please don’t hesitate to contact us if you are interested in our service.

Reference

  1. Food and Drug Administration (2008). Draft Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products. Biotechnology Law Report, 27(6), pp.568-577.

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