Opthea completes process performance qualification (PPQ)
The PPQ campaign consisted of the production of 3 successful consecutive commercial-scale drug substance batches required for the validation of Opthea’s manufacturing process.
(Image credit: AdobeStock/Renata Hamuda)
Opthea has completed its drug substance process performance qualification (PPQ) campaign for sozinibercept, marking a milestone in the company’s road to commercially scaling production of sozinibercept.
The PPQ campaign consisted of the production of 3 successful consecutive commercial-scale drug substance batches required for the validation of Opthea’s manufacturing process. According to the company’s news release, the batches were produced following an extensive manufacturing process development program.
Fred Guerard, PharmD, and CEO of Opthea shared his thoughts on this step in the development and manufacturing process, saying, “The successful completion of the drug substance PPQ campaign is an important step towards de-risking the program and a potential biologics license application (BLA) filing of sozinibercept in wet AMD. While we continue to advance our 2 fully enrolled, pivotal Phase 3 trials of sozinibercept in wet AMD, we now have demonstrated our ability to consistently manufacture quality drug substance at commercial scale, which will serve as a key component of our BLA Chemistry, Manufacturing and Controls (CMC) module.”
Mark O’Neill, Vice President of Technical Operations for Opthea, “In achieving this commercialization milestone, we believe Opthea is well positioned to supply both our planned drug product PPQ campaign, as well as our initial launch materials,” “We expect to share a progress update of our drug product PPQ campaign in early 2025.”
