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Adeno-associated viruses (AAV) have emerged as a promising gene therapy vector for a variety of human diseases. A major obstacle to expanding the use of AAV remains the limited capacity of existing production systems to provide sufficient quantities of AAV for clinical applications and commercial production. Creative Biogene is bringing a quantum leap forward in the manufacture of AAV with years of research and experience in the field, providing a cost-effective, easily scalable AAV production process.
As more and more AAV-based therapies enter the clinic, the challenges of AAV production technology must be overcome to better meet clinical and commercialization demands. Although many reports claim to have addressed the issue of scalable AAV production. However, few of these processes can be developed into robust and cost-effective AAV production methods. Creative Biogene is committed to developing and improving upon the limitations of existing AAV production methods to provide customers with a variety of robust, scalable AAV production processes.
A producer cell line integrates in its genome all the components required for AAV production, i.e., the rep and cap genes, as well as the genome of the vector containing the transgene expression cassette of interest. Infection requires the use of a helper virus (usually wild-type Ad5) to induce AAV production. Even though the three plasmid-based transient transfection method is currently being used for AAV production in many clinical trials, there are complications associated with scalability and it is not cost-effective. To address this issue, we developed a cell line-based stable production. By transfecting a universal helper plasmid into cells first to make a stable cell line, and then transfecting it with the AAV gene of interest, convenient production of AAV can be achieved. With this cell line, we can achieve rapid and efficient AAV production by transfecting only one plasmid in our GMP AAV production plant.
Fig. 1 Production of AAV based on stable cell line.
At Creative Biogene, we are committed to creating optimized, scalable and cost-effective AAV production processes. This is achieved by leveraging knowledge of AAV virus transfection, AAV purification, and AAV analysis. Our experts provide comprehensive solutions in cell line selection and culture, upstream and downstream cell manipulation, and quality analysis method development to streamline your process.
Creative Biogene is your CDMO partner with successful scale-up experience in large-scale AAV production. Our robust, scalable AAV production process will help you translate your R&D projects into clinical applications and commercial markets. Please feel free to contact us if you have a need, and our experienced specialists will be happy to assist you.
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