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ASGCT 2024 in Review: Spotlight on Forge’s Innovative Technical Posters

By Forge Biologics
Jun 10, 2024 11:51:54 AM

ASGCT 2024 in Review: Spotlight on Forge’s Innovative Technical Posters

At ASGCT 2024 in Baltimore, Maryland, the
gene and cell therapy industry showcased the exciting advancements being made to bring more potentially life-changing treatments to patients. Our technical and regulatory teams presented their groundbreaking science, highlighting Forge's pivotal role in advancing the industry by improving the accessibility of genetic medicines through better manufacturing and expertise with molecular improvements, process improvements, and integrated regulatory expertise. If you missed our poster presentations at ASGCT, we've made them available here for easy access.


Hear Danielle Sexton, Associate Director of Upstream Process Development, highlight her top takeaways from ASGCT 2024.


Molecular Improvements  

The Sixth Element: Identification and Evaluation of the Adenovirus L4 22/33K Region as a Requirement for Adeno-Associated Virus Production 

Poster Presenter: Angela Adsero, Ph.D. 

It has been understood for decades that specific adenoviral (Ad) genes/proteins are responsible for helping to generate adeno-associated virus (AAV) vectors. The prevailing knowledge in the field has been that five Ad elements are necessary and sufficient to provide the Ad helper functions for AAV production: E1a, E1b, E2a, E4ORF6, and VA RNA. The studies within this poster demonstrate, however, that one Ad gene in particular has been overlooked. By using molecular techniques to investigate the nature of this sequence, we were able to identify that the gene for a small protein (L4 region 22K protein) encompassed within this E2a regulatory region is required for AAV vector production. The study also suggests that the L4 region 33K protein may increase production yields of AAV. The decoupling of this Ad dual-purpose region and the discovery of previously unnoticed roles for the L4 22K and 33K genes in AAV production highlights the importance of continued scientific exploration that will drive innovation and improvements in AAV manufacturing. This novel finding will have a substantial impact on gene therapy since it allows for the reduction and modification of the supplied Adenoviral DNA needed for AAV production. This leads to additional avenues to optimize in improving AAV manufacturability and potentially safer AAV gene therapies. 

ASGCT24 poster Sixth Element


Process Improvements  

Upstream Process Development for Scalable, Suspension HEK 293 rAAV Production in Single-Use Bioreactors  

Poster Presenter: Danielle Sexton 

As the need for gene therapy medicines increases, being able to meet the needs of patients quickly will require a novel approach to process development. Optimizing individual process steps, like transfection and harvest, can increase yields without significantly increasing overall timeline. Leveraging experience and understanding of rAAV, along with the platform process, Forge can help partners meet the patient demand with targeted development focused on the most critical variables that drive robust process. 

ASGCT24 Upstream PD


From Benchtop to Cleanroom - Designing an Optimized Platform Purification Process for rAAV Production to Meet the Growing Demand.  

Poster Presenter: Blake Gursky 

Forge’s platform process for purification of rAAVs involves a multistep procedure involving clarification, affinity chromatography, full capsid enrichment, and tangential flow filtration for the robust and highly scalable production of rAAVs, with each processing parameter finely tailored to the individual program’s needs. With industry-leading technologies and a commitment to quality, Forge Biologics is strategically positioned to take on the most challenging of rAAV productions from the benchtop to the cleanroom.  

ASGCT24 poster Benchside to Cleanroom


Integrated Regulatory Solutions 

Regulatory Agility: Value of CDMOs Utilizing Platform Technology 

Poster Presenter: Angela Coy, Ph.D. 

One-off approaches for cell and gene therapies will be very cumbersome as the industry continues to develop more rare disease therapies for patients in need. Developers need well-defined manufacturing platforms and established vectors, or “building blocks”, that can be leveraged across platforms in order to meet the growing demand for patients. Forge has developed an AAV manufacturing platform that lowers development costs (less upfront investment of time and effort), speeds scale-up, and includes a process with built-in characterization and previous regulatory exposure.  

ASGCT24 poster Reg Agility


The Potential of Global Regulatory Harmonization in Gene and Cell Therapy 

Poster Presenter: Claire Marasco  

Global regulatory convergence has the potential to enable faster and more widespread patient access to gene therapy products, especially for rare disease indications. Success in this area has been demonstrated by Project Orbis. This presentation will share how industry groups, regulators, and standards-coordinating bodies are taking action to promote convergence. With robust discourse and careful alignment on expectations and priorities in the evaluation of gene therapy products, there is an opportunity to create the scale of success seen with Project Orbis, enabling access to life-changing medicines for patients across the globe. 

ASGCT24 poster Global Reg Harmonization


Want to Know More?

Click here to learn more about Forge and speak with our AAV experts.