Adeno-Associated Viruses Adherent Scale-up | AAV Gene Therapy Solutions | Corning

Fast Tracking Discovery—From Lab to Market

Fast Tracking Discovery—From Lab to Market

The ever-changing landscape of gene therapy has led to therapeutic developments for conditions once thought untreatable, as well as improvements in existing medical interventions. The use of viral vectors has become increasingly important in cell culture for gene therapy applications and requires a reliable, reproducible, and efficient scale-up platform to streamline time to market.

One of the most widely used viral vectors are adeno-associated viruses (AAVs), as they offer several advantages, such as:

  • Ease of genetic manipulation
  • Lack of replication
  • Accepting of large transgene DNA inserts
  • Robust transgene-specific T and B response

In order to support AAV adherent scale-up, Corning offers a portfolio of innovative solutions—from the new Ascent™ Fixed Bed Reactor (FBR) System to our HYPERStack®, CellStack®, and CellCube® culture vessels. Look to our decades-long expertise in cell culture product development, and our knowledgeable field application support specialists, to help guide your next gene therapy discovery.

Cell Therapy Production Ebook

Featured Technology

Corning® Ascent FBR System

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Corning® Ascent FBR System

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A major challenge for manufacturing adherent cells for advanced therapies is producing the large quantities of cells needed in a cost-effective manner. To address this need, Corning developed the Ascent FBR System, specifically designed to combine the greater yield efficiency, flexibility, and viable cell harvest capability of adherent bioproduction platforms, with the scale and automation of suspension manufacturing systems.

A major challenge for manufacturing adherent cells for advanced therapies is producing the large quantities of cells needed in a cost-effective manner. To address this need, Corning developed the Ascent FBR System, specifically designed to combine the greater yield efficiency, flexibility, and viable cell harvest capability of adherent bioproduction platforms, with the scale and automation of suspension manufacturing systems.

Features
Corning® Ascent FBR System

The Ascent FBR System:

The Ascent FBR System:

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  • Features an innovative bioreactor designed to enable uniform media flow and uniform high-density cell growth
  • Demonstrated to achieve greater than 90% transfection efficiency and high AAV-GFP vector yield/m2, which can reduce required runs and result in substantial cost savings
  • Enables viable cell harvests for seed train and total viral particle capture and a path for other applications, such as stem cell therapy workflows
  • Multiple Ascent FBR formats, from a 1 m2 benchtop system to 1,000 m2 production system, are planned to help create a stable and well-defined manufacturing process
  • Allows for the use of chemical (detergent) or mechanical (freeze/thaw, micro fluidization) cell lysis method for the release of cell-associated viral vectors
  • Features an innovative bioreactor designed to enable uniform media flow and uniform high-density cell growth
  • Demonstrated to achieve greater than 90% transfection efficiency and high AAV-GFP vector yield/m2, which can reduce required runs and result in substantial cost savings
  • Enables viable cell harvests for seed train and total viral particle capture and a path for other applications, such as stem cell therapy workflows
  • Multiple Ascent FBR formats, from a 1 m2 benchtop system to 1,000 m2 production system, are planned to help create a stable and well-defined manufacturing process
  • Allows for the use of chemical (detergent) or mechanical (freeze/thaw, micro fluidization) cell lysis method for the release of cell-associated viral vectors

Products

Featured Resources

Studies Supporting Corning Cell Cultureware for Gene Therapy Applications

Studies Supporting Corning Cell Cultureware for Gene Therapy Applications

Studies Supporting Corning Cell Cultureware for Gene Therapy Applications

Review a bibliography of published papers supporting the use of Corning cell expansion cultureware in cell, immune, and gene therapy applications.

Review a bibliography of published papers supporting the use of Corning cell expansion cultureware in cell, immune, and gene therapy applications.

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Corning CellCube® for Attachment-dependent Cells

Corning CellCube® for Attachment-dependent Cells

Corning CellCube® for Attachment-dependent Cells

The Corning CellCube system provides a simple, compact, and scalable method for mass culture of attachment-dependent cells.

The Corning CellCube system provides a simple, compact, and scalable method for mass culture of attachment-dependent cells.

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PEIpro® Transfection Protocol With CellSTACK

PEIpro® Transfection Protocol With CellSTACK

PEIpro® Transfection Protocol With CellSTACK

Review a recommended procedure for chemical-based DNA transfection using PEIpro transfection reagent in Corning CellSTACK culture chambers.

Review a recommended procedure for chemical-based DNA transfection using PEIpro transfection reagent in Corning CellSTACK culture chambers.

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CellCube Culture System Cell Expansion

CellCube Culture System Cell Expansion

CellCube Culture System Cell Expansion

See a protocol for using the Corning CellCube system to provide a simple, compact, and scalable method for mass culture of attachment-dependent cells.

See a protocol for using the Corning CellCube system to provide a simple, compact, and scalable method for mass culture of attachment-dependent cells.

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Amplifying Adenoviral Particles in the Corning HYPERStack Cell Culture Vessel

Amplifying Adenoviral Particles in the Corning HYPERStack Cell Culture Vessel

Amplifying Adenoviral Particles in the Corning HYPERStack Cell Culture Vessel

Discover how to expand your adherent cell culture for gene therapy workflows with Corning HYPER Technology.

Discover how to expand your adherent cell culture for gene therapy workflows with Corning HYPER Technology.

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Do more with Corning HYPERStack Cell Culture Vessels

Video: Do more with Corning HYPERStack Cell Culture Vessels

Video: Do more with Corning HYPERStack Cell Culture Vessels

See how this closed system offers more surface area within a compact footprint.

See how this closed system offers more surface area within a compact footprint.

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Improving Scale-up Efficiency with Corning® HYPER Technology Ebook

Improving Scale-up Efficiency with Corning® HYPER Technology Ebook

Improving Scale-up Efficiency with Corning® HYPER Technology Ebook

A compilation of research experiences in stem cell, viral vector and vaccine production.

A compilation of research experiences in stem cell, viral vector and vaccine production.

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Blog Series

Hear From Experts in the Field of Gene Therapy

Dyno Therapeutics Scaling Up AAV Production using Ascent Fixed Bed Bioreactor System

Dyno Therapeutics Scaling Up AAV Production using Ascent Fixed Bed Bioreactor System

Learn how Corning scale-up solutions are assisting our customers with their gene therapy development.

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Transfection Best Practices for AAV Gene Therapy

Transfection Best Practices for AAV Gene Therapy

Through an expert Q&A, learn about how to optimize transfection-based methods to deliver productivity, consistency, and scalability.

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Automated Manipulator

Optimize Your Viral Vector Workflow

Learn about the latest trends in viral vector production to help enhance vaccine research development.

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Best Practices for Vaccine Production

Best Practices for Vaccine Production

Discover four best practices for scaling up vaccine production process development from an expert in the field.

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Process Development in Gene Therapy: 4 Things to Know

Process Development in Gene Therapy

This article presents 4 expert-recommended essentials for scaling up your gene therapy process.

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Chris Suarez

Vaccine Production: Which Platform Is Best?

Making the right choice requires scientists to consider a range of factors, from surface area to scale.

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Comparing Gene Transfer Tools: Adeno-Associated Virus and Lentiviral Vectors

Adeno-Associated Virus and Lentiviral Vectors

AAV and LV vectors can be appealing alternatives to adenoviruses for researchers engaged in viral vector work. Let’s compare the two.

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Suspension or Adherent: Which Method is Right for Your Lab?

Comparing Suspension and Adherent Cell Culture

Vessel choice is influenced by a myriad of operational and biological factors, such as scale, resources, timing, cell type, and how much — or how little — culture inspection and parameter control is required. 

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Optimizing Vaccine Production Through Customization

Optimizing Vaccine Production

Because each vaccine is a unique modular process, single-use technologies and modular production facilities may be the future of the most efficient and cost-effective vaccine development.

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Education and Solutions for Gene Therapy

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Support

Application Support for Gene Therapy

Support
Scientist on computer

Specialized Support—from Process development to Commercial Scale Manufacturing

Specialized Support—from Process development to Commercial Scale Manufacturing

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Corning Field Application specialists are available to support your next gene therapy innovation.  Support teams can help you:

 

  • Scale from research to commercial production
  • Reduce manufacturing time and drive down production costs
  • Leverage our product expertise in research-scale immune cell culture to enhance your research goals

Put our seasoned experts to work for you.

Corning Field Application specialists are available to support your next gene therapy innovation.  Support teams can help you:

 

  • Scale from research to commercial production
  • Reduce manufacturing time and drive down production costs
  • Leverage our product expertise in research-scale immune cell culture to enhance your research goals

Put our seasoned experts to work for you.

Contact Us
Quality
Scientist holding up testube

Quality that Supports the Path from Research to Production

Quality that Supports the Path from Research to Production

From quality control protocols to sterility testing to meeting regulatory criteria, our tried and true manufacturing processes and practices are designed to ensure that every product delivers consistent, reliable results.

 

Our product development protocol includes:

  • A proven quality management system
  • USP Class VI testing
  • Meeting nonpyrogenic criteria
  • BSE/TSE
  • Sterility
  • Quality control testing

From quality control protocols to sterility testing to meeting regulatory criteria, our tried and true manufacturing processes and practices are designed to ensure that every product delivers consistent, reliable results.

 

Our product development protocol includes:

  • A proven quality management system
  • USP Class VI testing
  • Meeting nonpyrogenic criteria
  • BSE/TSE
  • Sterility
  • Quality control testing
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