AdAlta and Partners Target Cell Therapy Scale-Up with Automated IRO Platform

Automating Cell Therapy Manufacturing to Overcome Cost and Scale Barriers

AdAlta Limited (ASX:1AD) has teamed up with Oribiotech Ltd and Cell Therapies Pty Ltd (CTPL) to tackle one of the most stubborn challenges in cell therapy: manufacturing at commercial scale. The trio signed a Memorandum of Understanding to introduce Oribiotech’s IRO® platform, an automated cell therapy manufacturing system, to Australia and the broader Asia Pacific region. This move targets the high costs, slow production times, and inconsistency that have historically hindered the widespread adoption of CAR-T therapies.

Oribiotech’s IRO platform promises a step change in manufacturing efficiency, boasting a potential 10 to 50-fold increase in throughput within the same physical footprint, alongside reductions in manufacturing time and batch failures. Cost savings of 30–50% are projected, which could be transformative in a sector where production expenses have limited patient access globally. The platform’s digital tools also facilitate rapid process optimisation and smoother technology transfer, critical for scaling.

Strategic Fit with AdAlta’s Solid Cancer Pipeline

AdAlta’s CEO Dr Tim Oldham emphasised the alignment between IRO’s capabilities and the company’s “East to West” strategy, which integrates Asia’s cell therapy innovation with Australia’s clinical and manufacturing expertise. This partnership is designed to underpin AdAlta’s ambition to deliver scalable, cost-effective cellular immunotherapies for solid cancers, a notoriously difficult area where current therapies remain limited.

Notably, AdAlta’s lead product, BZDS1901, has already demonstrated promising clinical results, including complete tumour clearance in up to 20% of advanced mesothelioma patients, as detailed in recent trial updates showing rare tumour disappearances. However, while BZDS1901 benefits from shorter and lower-cost manufacturing, many other pipeline candidates could gain significantly from IRO’s automation to improve scalability and cost efficiency.

CTPL’s Role and Regional Manufacturing Leadership

Cell Therapies Pty Ltd, with over two decades of experience manufacturing advanced cell and gene therapies in Australia and Asia Pacific, will deploy the IRO platform for process development and clinical manufacturing. CTPL’s CEO Dr Bev Menner highlighted that access to IRO could attract commercial CAR-T programs to the region and accelerate the development of scalable therapies, enhancing patient access.

This collaboration positions CTPL as a leading contract development and manufacturing organisation in the Asia-Pacific, complementing AdAlta’s vision of globalising cellular immunotherapies from East to West. The partnership’s regional focus reflects growing momentum in Asia Pacific’s biomanufacturing capabilities and demand for innovative cancer treatments.

Regulatory Endorsement and Industry Validation

Oribiotech’s IRO platform has received the US FDA’s Advanced Manufacturing Technology (AMT) designation, a significant endorsement that signals reduced regulatory uncertainty and a clearer path from early development to commercial launch. The AMT program encourages adoption of technologies that enhance manufacturing reliability and scalability, underscoring IRO’s potential to set a new standard in cell therapy production.

To date, IRO has completed over 900 characterisation runs across more than 80 donor and patient samples, been used in 11 different cell manufacturing processes, and gained approval for its first clinical trial in China, with the first patient dose pending. It is already deployed with 14 cell therapy developers, contract manufacturers, academic medical centres, and large pharma companies.

This latest collaboration follows AdAlta’s recent progress in clinical development and manufacturing partnerships, including the acceleration of the BZDS1901 CAR-T therapy development with Shanghai Cell Therapy Group, reflecting a broader strategy to streamline regulatory pathways and manufacturing scale-up across multiple jurisdictions.