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The gene therapy industry is rapidly making progress in effectively treating and control diseases based on regulatory approvals. With that comes the need to continuously find efficiencies and optimize manufacturing processes to deploy gene therapies economically and at scale.

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Scale-up production processes with viral vectors

As the gene therapy industry continues to grow and more adeno-associated virus (AAV)–based gene therapies achieve regulatory approval, establishing a seamless path-to-market is becoming increasingly important. One challenge that manufacturers are currently facing during this process is the transition from research and development to clinical trials and commercialization—specifically, balancing the need to scale up production volumes while maintaining consistent quality.

Central to achieving efficient workflow scale-up are scalable and consistent components. This is because the scalability of the cell culture media and transfection reagents used can have a major impact on process performance.

Additionally, as you move to commercial manufacturing, it is more important than ever for workflow components to be consistent in terms of both quality and supply. By offering innovative Gibco products and dedicated support services backed by a robust global manufacturing network, Thermo Fisher Scientific can help you scale up your AAV manufacturing workflow with confidence and meet your project goals.

  • Article: Straight from the source: Streamlining scale-up with quality raw materials
  • Brochure: Scaling up AAV production with Thermo Fisher Scientific gene therapy solutions
  • Infographic: Raw material demands for gene therapy development

  • AAV manufacturing process optimization

    Gene therapy is proving to be a powerful potential treatment option, leading to increasingly high demand. Although timelines are being compressed, it is critical for manufacturers to think about the sustainability and future of their upstream processes. By considering the long-term feasibility of their workflows in the earlier stages of development, manufacturers have a greater chance of maintaining productivity and preventing later process changes, which can be costly and time-consuming.

  • Article: The keys to achieve success with commercial AAV manufacturing scale-up
  • Article: Format follows function: Media considerations for future-proofing AAV manufacturing processes
  • Article: The future of AAV manufacturing: A multidisciplinary perspective

  • Bioprocessing resources

    Access a targeted collection of scientific application notes, case studies, posters, white papers and more for bioprocessing:

    For Research Use or Further Manufacturing. Not for diagnostic use or direct administration into humans or animals.