Policy & Regulation
AGC Biologics to manufacture AAVantgarde's dual-vector gene therapies for inherited retinal diseases
21 November 2025 -

AGC Biologics, a global biopharmaceutical Contract Development and Manufacturing Organisation (CDMO), on Friday announced a manufacturing agreement with clinical-stage biotechnology company AAVantgarde to produce two dual-vector gene therapy candidates targeting inherited retinal disorders.

This partnership follows AAVantgarde's recent Series B financing and reinforces AGC Biologics' momentum in the adeno-associated virus market.

Under the agreement, AGC Biologics will provide GMP manufacturing for AAVB-039, a Phase 1/2 therapy for Stargardt disease, and AAVB-081, a Phase 1/2 therapy for retinitis pigmentosa caused by Usher syndrome type 1B. Both programmes address forms of progressive, irreversible vision loss that currently lack approved treatments.

The projects will use AGC Biologics' BravoAAV suspension platform and a dual-vector design that enables delivery of genes too large for a single AAV vector. This approach allows the therapeutic gene to be split, packaged separately, and reassembled inside target cells.

Manufacturing will be conducted at AGC Biologics' Milan Cell and Gene Center of Excellence, which has a 30-year track record and 10 regulatory approvals from European and US authorities.

The BravoAAV platform is designed to accelerate development timelines from gene to clinic to as little as nine months.

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