Latest Manufacturing Processes News

AdAlta and Shanghai Cell Therapy Group have approved the FDA briefing pack and manufacturing transfer plan for EW-001, bringing the mesothelioma CAR-T therapy closer to an Australian Phase 1 trial. The FDA meeting is scheduled for November, while two Chinese patients remain under follow-up, including a second complete responder.

First Graphene has signed a three-year agreement with Turkish manufacturer Aeropreg to develop and potentially commercialise PureGRAPH-enhanced carbon fibre prepreg. The partnership offers a clearer route into aerospace, defence and automotive supply chains, but commercial launch remains dependent on trial results.

Mesoblast has secured FDA approval to add a new potency assay to commercial release and stability testing for Ryoncil, its approved cell therapy for paediatric graft-versus-host disease. The regulatory decision supports tighter monitoring as manufacturing processes evolve, but the company disclosed no direct financial impact or clinical outcome data.

AdAlta has secured a formal US FDA pre-IND meeting for EW-001, moving its mesothelioma CAR-T therapy into a critical regulatory review. The November meeting will test the company’s Australian manufacturing, remaining studies and proposed Phase 1 trial before the more expensive stages of development begin.

AdAlta says a 10-year, up to US$120 million agreement between manufacturing partner Oribiotech and an undisclosed commercial-stage biopharmaceutical company validates its choice of IRO automation for future cellular immunotherapies. The deal does not create direct revenue for AdAlta, and its lead asset EW-001 will continue with a separate manufacturing process.

Imagion Biosystems has signed nanoComposix to resume GMP-aligned manufacturing of the MagSense nanoparticle core, a move designed to support its FDA-cleared HER2 breast cancer programme without the fixed cost of an in-house facility. The agreement improves manufacturing readiness, but its value, duration and production commitments remain undisclosed.

OncoSil Medical has moved closer to local production after contract manufacturer Cyclotek secured ISO 13485 certification for its quality management system. Production at the Macquarie Park facility remains targeted for the end of 2Q FY27, subject to further regulatory approval.

Arovella Therapeutics has released the first clinical batch of its off-the-shelf cell therapy ALA-101 and activated its inaugural trial site at The Alfred, setting the stage for patient dosing later this month.

AdAlta’s partner SHcell has gained regulatory approval to provide the BZDS1901 CAR-T therapy to advanced mesothelioma patients in China’s Hainan Boao Lecheng special access zone, marking a key milestone in real-world data collection and treatment availability.

Actinogen Medical has locked in full underwriting for nearly 127 million unlisted options, guaranteeing $4.77 million in fresh funding as it approaches pivotal Alzheimer’s trial results due in November.

Advance ZincTek posted an 11% rise in FY26 profit before tax to $2.247 million on 12.6% higher sales, driven by AI integration and US market strength. The company is set to enter residential battery manufacturing in FY27, leveraging its zinc oxide expertise.

Actinogen Medical reported a $15.38 million loss for FY2026 while progressing its lead Alzheimer's drug Xanamem toward pivotal trial results expected this November. The company secured regulatory alignment and strengthened its cash position to fund operations through mid-2027.