Seattle, May 6 (Korea Bizwire) — AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), has announced its partnership with Oculis to manufacture OCS-02, a Phase II investigational drug targeting both Dry Eye Disease and Anterior Uveitis, at its Heidelberg facility.
“We are very pleased that Oculis has chosen us to manufacture this treatment,” says AGC Biologics Chief Business Officer, Mark Womack. “Our Heidelberg site has the experience and expertise to deliver this program from early phase to market.”
OCS-02 is a tumor necrosis factor-alpha (TNF alpha) inhibitor. TNF alpha is a proven biological target in ocular inflammation with possible dual actions: anti-inflammation and anti-necrosis. The OCS-02 compound is based on a proprietary single-chain antibody fragment technology specifically designed for topical delivery. The efficacy and safety of OCS-02 were evaluated in three clinical trials including two controlled studies under IND. The studies demonstrated a promising profile for treating ocular inflammatory conditions of the anterior segment of the eye including Dry Eye Disease and Non-Infectious Anterior Uveitis.
“The Heidelberg team is excited to advance the process and analytics for this molecule to the next phase and is looking forward to a close collaboration with the Oculis team,” says AGC Biologics General Manager, Heidelberg, Dieter Kramer.
AGC Biologics’ Heidelberg facility has over 20 years of experience delivering a very wide range of microbial programs. In addition, the site is AGC’s Center of Excellence for Plasmid DNA (pDNA) production, as part of their end-to-end Cell and Gene Therapy offering.
About AGC Biologics:
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), viral vectors and genetically engineered cells. Our global network spans the U.S., Europe and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan and we currently employ more than 1,700 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com.
About Oculis:
Headquartered in Lausanne, Switzerland with global operations in Europe and the U.S., Oculis is a biopharmaceutical company focused on developing transformative innovative ophthalmic treatments to improve the sight and lives of patients. Oculis has a robust and expansive development portfolio including late-stage novel topical (eye drop) treatments, which are non-invasive and represent an unprecedented technical advance for patients with retinal edema and front-of-the-eye diseases. In addition, Oculis’ formulation discovery and innovation capabilities enable the development of a pipeline of topical drugs targeting sight-threatening eye diseases that affect both the anterior and posterior segments of the eye. To learn more, please visit www.oculis.com
David Self
AGC Biologics
dself@agcbio.com
Source: AGC Biologics via GLOBE NEWSWIRE