Design for Success:
AAV Molecular Development Services
Ensure your molecular foundation is designed for AAV manufacturing success. Forge provides molecular development consultation services, including plasmid and construct evaluations, functional screening, and process guidance to reduce risk and accelerate readiness for cGMP production.
Key Capabilities: Plasmid & Construct Design Assessment
Forge’s molecular development consultation services help developers understand how their existing plasmid and construct designs may perform in manufacturing. By evaluating critical sequence elements and their potential impact on productivity, stability, and safety, we provide actionable insights that reduce risk and support a smoother path to cGMP readiness, including:
ITR integrity, cassette size, regulatory element evaluation
ITR integrity, cassette size, regulatory element evaluation
We confirm the accuracy and stability of inverted terminal repeats (ITRs), which are essential for efficient AAV packaging, and assess the overall size of the transgene cassette to ensure compatibility with vector capacity. In addition, we evaluate regulatory elements—such as promoters, enhancers, and polyadenylation signals—to predict their functionality.
Predicting impact on yield and stability
Predicting impact on yield and stability
We analyze design features that directly influence productivity and product quality, such as secondary structures, GC content, and sequence motifs that may reduce yield or increase degradation. This predictive assessment allows for informed decisions on redesign or optimization to support higher titers and greater consistency.
Identifying homology and recombinogenic risks
Identifying homology and recombinogenic risks
Our team screens plasmid designs for unwanted homology and recombinogenic hotspots that can compromise construct stability during manufacturing. By identifying and mitigating these risks early, we help clients avoid costly setbacks in plasmid production, vector packaging, and clinical-scale manufacturing.
With Forge’s plasmid and construct assessment, gene therapy developers gain confidence that their designs are optimized for manufacturability. Our insights accelerate the transition from research concepts to scalable, cGMP-ready programs, enabling a stronger foundation for clinical and commercial success.
Our Integrated Workflow for Vector Design Consultation
Our end-to-end process begins with a collaborative molecular development consultation and flows through to vector design and production.
Your Checklist for Plasmid Design and AAV Manufacturability
Our checklist for developers highlights key quality control checkpoints during the molecular development process. Specific sequence features must be verified to ensure proper AAV vector production, transgene expression, and safety, and ensure robust plasmid performance and AAV manufacturing success.
Case Study Success
Real-world examples highlight how Forge’s molecular development services and process optimization strategies create measurable impact for clients. By addressing risks early and applying structured, data-driven approaches, Forge helps ensure programs are scalable, compliant, and efficient.
Eliminating rcAAV Risk and Boosting Productivity
With Forge’s redesigned rep/cap plasmid, we eliminated rcAAV risk and also increased productivity five-fold.
Driving Yield Improvements with DOE + FUEL™ Platform
Combining design of experiments (DOE) methodology with our FUEL™ platform to optimize transfection parameters and upstream production led to productivity improvements of up to 22-fold compared to industry standard processes.
Connecting Development to AAV Manufacturing
Forge’s molecular development consultation isn’t a standalone service, it’s the starting point of a connected journey. Insights gained at the molecular level feed directly into process development, scale-up, and regulatory readiness. See how molecular insights flow into our AAV manufacturing:
FUEL™ Platform Advantage
Platform-driven productivity and quality
Process Development
Translating molecular data into optimized upstream and downstream workflows tailored to your program
cGMP Manufacturing
Seamless transition into clinical and commercial manufacturing at the Hearth, Forge’s purpose-built facility
Regulatory Support
Carrying forward early evaluation data to support INDs, comparability, and BLA submissions
By linking molecular consultation with end-to-end manufacturing, Forge helps clients move from sequence-level insights to scalable, compliant, and commercially viable AAV programs.
Partner with Forge for Expert AAV Molecular Development Consultation
Insights for Developers
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Christopher Shilling represented Forge and the gene therapy manufacturing sector at a recent public meeting hosted by the FDA regarding…
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This article first appeared in Endpoints News and highlights the growing importance of scalable, reliable AAV production as gene therapy…
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Bringing a gene therapy to market involves navigating the FDA’s complex Biologics License Application (BLA) process, which ensures products meet…
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23 Questions with Forge is a fast-paced series where team members answer rapid-fire questions on trending topics in gene therapy…