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TESSA® AAV Production Technology

Transforming AAV Manufacturing at Scale

Adeno-associated virus (AAV) is a backbone of many gene therapy programs, but traditional manufacturing methods have struggled with low yields, high costs and inconsistent product quality. TESSA® (Tetracycline-enabled Self-Silencing Adenoviral Vector) is Minaris’ proprietary, plasmid-free AAV production system that redefines scalability and quality.

By replacing transient plasmid transfection with a helper adenoviral vector that self-silences during production, TESSA® can deliver up to 30 times higher yields, with increased full-capsid percentages, reduced impurities and is seamlessly scalable to 2000L and beyond. This innovation enables gene therapy developers to accelerate clinical programs, reduce the cost of goods and prepare for commercial supply.

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Key Advantages of TESSA®

  • TESSA® routinely achieves up to 30-fold yield increases compared with plasmid transfections. In head-to-head studies, it produces up to 80% full capsids before enrichment using standard methods, compared with ~40% using standard methods.
  • Self-silencing adenovirus helper functions prevent late adenoviral gene expression, ensuring no helper vector is detectable in the final product. Host cell DNA and residual impurities are significantly reduced, supporting regulatory compliance and patient safety.
  • TESSA® has been demonstrated in 200L production runs and is scalable to 2000L and beyond, using suspension HEK293 platforms in bioreactors. This scalability provides developers with a direct path from lab to commercial-scale manufacturing.
  • Eliminating costly plasmid production and complex transfection processes lowers AAV manufacturing costs and reduces variability. Parallel scalability allows earlier adoption of commercial-ready processes, minimizing tech transfer risk between clinical and commercial stages.

Triple Transfection vs TESSA®

Traditional Triple Transfection
TESSA® AAV Platform

Production Method

Relies on three plasmids (rep/cap, helper and transgene plasmid) introduced by transient transfection

Uses engineered adenovirus vectors that provide helper functions and self-silence, eliminating plasmid transfection

Yield

Low to moderate, typically limiting scale

Up to 30x higher yield demonstrated in multiple programs

Full Capsids

~40% full capsids before enrichment

Up to 80% full capsids before enrichment, reducing purification burden and improving product consistency

Scalability

Difficult to scale consistently beyond hundreds of liters

Proven scalability to 200L with a pathway to 2000L+, supporting commercial-scale manufacturing

Cost of Goods

High, due to plasmid production and transfection inefficiencies

Lower COGSs, as plasmid production is eliminated and processes are simplified

Safety Profile

Residual plasmids and helper contaminants must be carefully removed

No helper adenoviral vector detected in final product; reduced host cell DNA contamination

How TESSA® Works

TESSA® leverages adenovirus biology in a novel way. The engineered vector provides all necessary helper functions for AAV replication but incorporates a tetracycline repressor feedback loop that shuts down adenoviral structural protein expression. This ensures that the adenoviral vectors do not replicate in the bioreactors during AAV production, providing a clean and contaminant-free manufacturing process.

Two TESSA® formats are available:

TESSA® Duo

Uses two adenoviral vectors, one carrying the rep/cap genes and another carrying the therapeutic transgene. This system enables precise control of vector design and robust co-infection efficiency. Suitable for large-scale clinical trials and high-dose indication programs.

TESSA® Pro

An enhanced system with >5000-fold AAV amplification, optimized for high yields and full capsid ratios. Suitable for discovery and early-phase programs.

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Industry Validation and Adoption

  • TESSA® has been licensed by Janssen (Johnson & Johnson) for its gene therapy programs.

  • TESSA® produced up to 30-fold yield increases compared with plasmid transfections.

  • TESSA® reduces overall COGs by more than 85% on the commercial scale.

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Why TESSA® Matters for Gene Therapy Developers

Gene therapy’s commercial success relies on solving manufacturing bottlenecks. TESSA® resolves these by:

  • Supporting large-scale production with consistent product quality
  • Enabling cost-effective clinical supply without reliance on expensive plasmids
  • Reducing risk through early adoption of scalable, regulatory-ready processes
  • Delivering higher-quality vectors that improve patient safety and therapeutic performance

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Minaris Advanced Therapies is dedicated to helping innovators in cell and gene therapy succeed. Whether you are in early-stage development or preparing for commercial launch, our end-to-end expertise, global reach and commitment to quality make us the ideal partner for cell and gene therapy manufacturing and GMP biosafety and analytical testing of all biologics.

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