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INDUSTRIES

Redefining Adeno-Associated Virus Manufacturing

Accelerate your cell therapy to the patient

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Fixed-Bed Innovation For Scalable Gene Therapy

Recombinant adeno-associated viral vectors (rAAVs) are the backbone of many gene therapy platforms due to their safety, tissue specificity, and long-term expression. Human Embryonic Kidney (HEK) cells, especially HEK293 derivatives, are widely used for rAAV production because of their high transient transfection efficiency, human origin, and compatibility with suspension-based bioprocessing despite their anchorage-dependent nature.

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Suspension-based rAAV manufacturing presents persistent challenges: inconsistent yields, high shear stress, substantial process volumes, changes to product quality (esp. for complex bio molecules) and challenging downstream processing. These issues affect reproducibility, cause losses in rAAV production efficiencies and delay clinical translation. 

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Antleron offers an alternative: a fixed-bed bioreactor technology tailored for adherent HEK cell culture, enabling robust, scalable, and GMP-ready rAAV production.

 

Our CellGuide® platform allows to grow adherent HEK cells at volumetric densities at least equivalent to the most performant suspension setup while considerably reducing the load on downstream purification. In this manner, Antleron aims to redefine the  scaling potential and process economies for adherent cell-based rAAV production. 

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Our Solutions For Cell & Gene Therapies

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Fixed-Bed Bioreactors

Designed for adherent cell growth, our fixed-bed systems provide a low-shear, high-surface-area environment that supports high-density HEK cultures. This results in: 

  • Effortless translation of culture plate-based bioprocesses

  • Seamless scale-up from as low as 25 cm² up to at least 90 000 cm² 

  • Surface area intensification

  • Advanced process analytics and control capabilities

  • Simple downstream processing of secreted products

  • Reduced batch variability

  • Predictable lab-to-production translation. 

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Digitally Enhanced Bioprocess Development

Increase your number of test conditions (you can run thousands of in-silico conditions!) and data through digitally conducted experiments to efficiently improve your bioprocess understanding, in turn allowing more robust optimization and control strategies, all at a fraction of the cost and time of typical bioprocess development runs. 

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Seamless Integration

Our CellGuide® platform’s adaptability and custom character supports integration with existing devices and workflows, solving identified bottlenecks, without re-inventing the wheel. 

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Antleron Services

We support gene therapy developers with tailored services that accelerate development and de-risk manufacturing: 

  • Process Development & Optimization

​Translation of culture plate-based protocols to the CellGuide® fixed-bed technology, co-development of robust, scalable rAAV production workflows, and setup of Digital Twins of the bioprocess based on critical process parameters and quality attributes. â€‹

  • CRO Services

Smart scaled-down model development and characterization, full biolab and analytical capabilities, simulation and modelling capabilities, production technology benchmarking and integration, feasibility studies, assay development, and potency testing tailored to thetherapeutic goals. 

  • Regulatory Support

Guidance on process mapping, definition of critical process parameters and their impact on quality attributes according to Quality by Design practices, comparability studies, and documentation for clinical trial submissions. 

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Antleron Track Record

​Antleron has successfully partnered with gene therapy innovators to: 

  • Transition from culture plates to fixed-bed rAAV production. 

  • Reduce development timelines and manufacturing costs. 

  • Efficiently conduct bioprocess optimization at small scale and in silico. 

  • Support regulatory submissions with robust process data. 

 

Our team combines deep expertise in HEK cell biology, viral vector production, and bioprocess engineering to deliver scalable, compliant solutions for gene therapy production. 

Antleron In Numbers

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Footprint

-81%

In comparison to an equivalent multi-tray system

Product harvest window

5-6 days

vs 2-3 days with traditional systems

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Time to market

2-10x

Cost reduction for bioprocess development

Reach out to us to explore how Antleron can answer your needs.

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Based on a first conversation, we will engage our team of experts to propose a solution tailored to your research, development and manufacturing challenges.

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