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Unlock the Future of Ocular AAV Therapy with ExoREADY™

Flexible AAV Manufacturing for Ocular Gene Therapies

Transform your vision into reality. Our ExoREADY™ platform empowers you to focus on designing your ideal ocular AAV therapy while we handle the complexities of manufacturing. With streamlined processes, tailored solutions, affordable licensing and transparent communication throughout your journey from concept to clinic.

Exothera understands the unique challenges of ocular gene therapy development and offers tailored solutions to empower your breakthrough  

Time and Cost

Unoptimized processes can lead to unexpected delays and increased costs. Our ExoREADY™ platform is pre-optimized to reduce the production timelines to ~9 months (vs compared to the 16-18 months of traditional custom methods).

Flexibility & Scalability

Small batches, particularly in clinical stages, may be required but not always available with larger CDMOs. We have the flexibility to take on projects of various sizes from 10L to 1000L as you progress your program from preclinical to commercial stages.

Product Quality

Robust QC analytics may not be always available in-house. With our in-house robust QC analytics, you can trust the quality and reliability of your product every step of the way.

Empty Capsids

Empty Capsids can result in reduced potency for your drug product. Our optimized ExoREADY™ process delivers consistently high full/empty ratios up to 95% full depending on serotype.

Regulatory Compliance

Upholding stringent quality standards with more inexperienced CDMOs can be an issue. We offer CMC consultancy to advise on regulatory aspects of your program.

Excessive licensing fees

Excessive licensing fees can result in unsustainable costs for production. The ExoREADY™ platform utilizes in-licensed cell lines and plasmids allow us to avoid licensing fees through phase 3 with competitive licensing rates for later stages.

Our optimized upstream process consistently delivers high harvest titer using ExoREADY™ cell line and plasmids

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ExoREADY™ downstream process performance meets industry standards for purity and potency

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From 10 to 1000L GMP batch sizes

Up to 1000 vials/shift

Final titers up to E13 VG/L

Our growing analytical portfolio includes:

Identity
  • Protein electrophoretic mobility (Capsid Identity): Western blot
Safety
  • Bioburden: Membrane filtration
  • Endotoxins: LAL
Purity
  • Process-related impurities — residual plasmid DNA: ddPCR
  • Process-related impurities — BSA: ELISA
  • Process-related impurities — Benzonase: ELISA
  • Host cell-related impurities — HCP: ELISA
  • Host cell-related impurities — HCD: ddPCR
  • Capsid content (full/empty capsid): AEX-HPLC
  • Protein purity: SDS-PAGE
  • Aggregate formation: SEC-HPLC
  • Visible particles: Visual inspection
Potency
  • Physical viral titer: ddPCR
  • Functional (infectious) viral titer: TCID50, plaque assay
  • Ratio of physical titer/infectious titer: Calculation
  • Protein concentration: A280
Appearance
  • Clarity and opalescence: Nephelometry
  • Color: Visual inspection
Other
  • pH: Potentiometry
  • Osmolality: Osmometry
  • Conductivity: Conductivity meter
  • Cell viability (cell bank, passages): Cell counter
  • Growth promotion (microbial culture media): Microbial enumeration
  • Growth promotion (cell culture media): Cell counter

Streamline Your Ocular AAV Development with ExoREADY™

Unlock the full potential of your research with ExoREADY™. Our advanced platform offers streamlined processes and tailored solutions to fast-track your ocular AAV projects from inception to commercialization.

In-House Analytical Expertise You Can Trust

Experience faster turnaround times and precise results with our in-house analytics. Gain greater control over quality and data integrity, reduce costs, and customize processes to meet your project's needs.

Adaptable to Your Needs

We understand you have specific requirements in terms of cost, recovery, and full/empty ratio. Our flexible platform allows us to tailor solutions to the ensure optimal outcomes.

Your AAV Partner, Beyond Ocular

Exothera's expertise spans a wide range of AAV applications. While we're actively engaged in the ocular space, our ExoREADY™ platform is equipped to support your gene therapy development across various indications. 

Contact us to learn more about our capabilities.

Any Questions For Us?

In Belgium, our state-of-the-art facilities, called VEGA and NOVA, are based on the Univercells Campus, in Jumet (Belgium), close to the Brussels South Airport. They offer 900 m² (9,687 ft²) of GMP production area for viral vectors and 500 m² (5,381 ft²) of ready-to-use production area for nucleic acids. 

In North America, our 800m² (8611 ft²). Research Center of Excellence for RUO RNA manufacturing is located in Andover, Massachusetts.

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Ready to Take the Next Step in Your Ocular AAV Journey?

Meet Our Experts

Ana Martini

Business Development Director

Oliver Dezutter

Business Development Manager

Manuel Valdes

Senior Director BD

Andrew
Klauk

Senior Inside Sales

Let's discuss how Exothera's ExoREADY™ platform can empower your next gene therapy breakthrough. Get in touch by completing the form below:

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