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Specialized Veterinary Care for Ocular Gene Therapy Studies in Rabbits in Switzerland

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Specialized Veterinary Care for Ocular Gene Therapy Studies in Rabbits in Switzerland

Specialized Veterinary Care for Ocular Gene Therapy Studies in Rabbit Models

CELL & GENE | RNA | BIOLOGICS

    What specialized ocular procedures do you support for rabbit models?

    A: We provide comprehensive support for subretinal, intravitreal, and suprachoroidal injections. Our veterinary staff is proficient in advanced in-life imaging techniques, including Optical Coherence Tomography (OCT), fundus photography, and electroretinography (ERG) to monitor efficacy and safety.

    How do you ensure GxP compliance for European regulatory submissions?

    A: Our operations adhere to a global GxP framework, ensuring all procedures meet international regulatory standards. We generate data packages suitable for Clinical Trial Authorisation (CTA) submissions to agencies like Swissmedic and the EMA, contributing to an 18-24 month development timeline.

    What is your approach to managing potential AAV vector immunogenicity?

    A: We integrate neutralizing antibody (NAb) screening into the study design. This proactive step, informed by findings such as those in PMID: 26067568, helps ensure that preexisting immunity does not confound study outcomes, which improves data integrity for AAV-based programs.

    How do you manage animal welfare for sensitive ocular studies in Europe?

    A: Our animal welfare framework is aligned with AAALAC International standards and complies with European Directive 2010/63/EU and the Swiss Animal Welfare Act. We implement the 3Rs (Replacement, Reduction, Refinement) through specialized post-operative pain management, environmental enrichment, and minimally invasive monitoring.

Executing ocular gene therapy studies in rabbit models requires highly specialized veterinary expertise to ensure data integrity and translational relevance. Standard in vivo protocols are insufficient for managing the complexities of AAV vector administration to the eye and the subsequent in-life monitoring. Franklin Biolabs provides dedicated GxP-compliant veterinary care and advanced imaging support for ophthalmic gene therapy programs, focusing on robust, reproducible study execution to support accelerated CTA submissions.

The Ocular Model: Requirements for Translational Success

The rabbit eye provides a valuable large-animal model for ocular gene therapy due to its anatomical similarity to the human eye. Its use, however, presents distinct operational challenges. Achieving precise vector delivery to target retinal cells while minimizing inflammation and procedural complications demands surgical proficiency and tailored anesthetic and analgesic protocols.

Post-administration monitoring is equally demanding. Capturing meaningful efficacy and safety data requires proficiency with sophisticated imaging and functional assessment technologies, including:

  • Optical Coherence Tomography (OCT) for structural analysis of the retina.

  • Electroretinography (ERG) to measure retinal cell function.

  • Slit-lamp examinations and fundus photography for clinical observation.

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Mitigating Biological Variables for CTA-Enabling Data

A successful CTA-enabling study hinges on controlling biological variables that can confound data interpretation. For AAV-based therapies, preexisting neutralizing antibodies represent a significant risk that can block vector transduction and obscure true therapeutic effect. We incorporate rigorous screening during the animal selection phase to de-risk studies and strengthen the final dataset.

This methodical approach to managing study variables is fundamental to generating a robust safety and efficacy profile, as seen in the successful translation of gene therapies for conditions like Krabbe disease (PMID: 35333110). By controlling variables from animal selection through final analysis, we produce data packages that withstand regulatory scrutiny. This contributes directly to our clients’ 100% IND/CTA application success rate for programs we have supported since 2019 (the Franklin Biolabs brand launched in 2024).

Animal Welfare and GxP Compliance

Franklin Biolabs’ global GxP operations, which include over 100,000 sq ft of research facilities, operate under a framework aligned with AAALAC International standards. Our protocols adhere to the stringent requirements of the Swiss Animal Welfare Act and European Directive 2010/63/EU, with oversight from the relevant ethical review bodies and cantonal authorities.

Our framework for animal welfare is built upon the 3Rs:

  • Replacement: Utilizing validated in vitro assays where applicable to reduce animal use.

  • Reduction: Employing advanced statistical designs to maximize data output from the minimum number of animals.

  • Refinement: Implementing specialized post-operative care, tailored environmental enrichment, and minimally invasive monitoring techniques to enhance animal well-being throughout the study lifecycle.

Scientific Process Diagram

This content is for informational purposes. For guidance specific to your therapeutic program, please contact our team for a consultation.

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