Clinical-stage biopharmaceutical company Opthea Limited (ASX: OPT) has completed its drug substance Process Performance Qualification (PPQ) campaign for sozinibercept.
The PPQ campaign consisted of the production of three successful consecutive commercial-scale drug substance batches required for the validation of Opthea’s manufacturing process. The batches have been produced following an extensive manufacturing process development programme.
“The successful completion of the drug substance PPQ campaign is an important step towards de-risking the programme and a potential biologics license application (BLA) filing of sozinibercept in wet AMD,” CEO, Fred Guerard, said.
“While we continue to advance our two 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.”
“In achieving this commercialisation milestone, we believe Opthea is well positioned to supply both our planned drug product PPQ campaign, as well as our initial launch materials,” concluded Mark O’Neill, Vice President, Technical Operations, Opthea. “We expect to share a progress update of our drug product PPQ campaign in early 2025.”
