Canary Bio Signs Commercial Production Agreement for Oregovomab with Cytovance

Canaria Bio announced on the 3rd that it has signed a commercial production contract for the ovarian cancer treatment Oregobomab with Cytovance, a contract manufacturing organization (CMO) based in Oklahoma, USA.

Cytovance has experience producing clinical samples of Oregobomab, which is being developed by Canaria Bio.

For the commercial production of Canaria Bio's Oregobomab, Cytovance will perform process characterization, production process validation, and process performance qualification (PPQ) batch production, and will undergo a pre-approval inspection by the FDA before product approval.

Canaria Bio recently recruited Dr. Nageichi, who worked as a production technology (CMC) reviewer at the US FDA for eight years, to prepare for commercial production. Dr. Nageichi will oversee the entire commercial production preparation process together with Cytovance.

CEO Han-ik Na stated, “Cytovance passed the FDA regular audit without any issues and is a company that understands the material characteristics of Oregobomab well. Additionally, they have minimized approval-related risks by maintaining all production-related variables of the commercial production process identical to those during clinical sample production.”

Regarding this contract, CEO Na said, “More than 20 billion KRW will be invested up to the PPQ batch production. This is not a contract that can be easily made without confidence in success. We are starting commercial production preparations now to file for product approval immediately after the global Phase 3 clinical trial concludes.”

This content was produced with the assistance of AI translation services.