Preclinical & CMC Services for AAV-Based Ocular Gene Therapies
From Preclinical Research to Clinical-Ready AAV Manufacturing
Pharmaron provides end-to-end preclinical and CMC services for AAV-based ocular therapies, ensuring efficacy, biodistribution, safety, and regulatory compliance. With over a decade of experience in ocular gene therapy development, our team supports IND, IMPD, and BLA submissions through high-quality preclinical studies and scalable AAV manufacturing.
We specialize in AAV preclinical testing for retinal and ocular diseases, with GLP toxicology studies, biodistribution analysis, and functional endpoints evaluation. Our state-of-the-art CMC facility delivers high-purity AAV manufacturing with chromatography-based purification and scalable suspension culture systems.
Key Preclinical & CMC Capabilities:
- Preclinical Study Design & Execution – Efficacy, biodistribution, GLP toxicology, and PK studies
- Broad Ocular Disease Models – Wet AMD, inherited retinal disorders, diabetic retinopathy, glaucoma, and more
- Regulatory Submission Support – IND, IMPD, and BLA dossier preparation for FDA & EMA approvals
- GMP-Ready AAV Manufacturing – Scalable production up to 500L with high-purity chromatography purification
- Advanced Analytical & Product Characterization – Bioassays, structural evaluations, and CMC regulatory compliance
With expertise in preclinical ocular AAV studies and CMC regulatory pathways, Pharmaron ensures successful AAV gene therapy development from discovery to market.
Why Choose Pharmaron for Ocular AAV Development?
- Over a Decade of Experience in Ocular Gene Therapy – Supporting IND & clinical submissions worldwide
- Regulatory-Ready Preclinical & CMC Support – Ensuring smooth transition from research to market approval
- State-of-the-Art GMP AAV Manufacturing – Scalable, high-purity ocular gene therapy production
Optimize your AAV gene therapy for ocular diseases. Download our service overview to explore Pharmaron’s preclinical & CMC solutions.