CSL to test Horizon 2 plasma process
- CSL Limited (ASX:CSL) will start clinical trials to test immunoglobulin made with its next‑generation Horizon 2 plasma manufacturing process.
- The decision does not immediately change financial guidance but marks a key step in CSL’s plan to use higher‑yield plasma technology.
- CSL (ASX:CSL) said the trials will support regulatory approvals for Horizon 2 after discussions with the US FDA and European Medicines Agency.
CSL Limited (ASX:CSL) will conduct clinical trials to confirm the efficacy and safety of immunoglobulin produced using its Horizon 2 next‑generation plasma manufacturing process, which it describes as yield‑enhancing technology.
The company said Horizon 2 is designed to deliver significantly more immunoglobulin from the same volume of plasma, and the trials follow engagements with the US Food & Drug Administration and European Medicines Agency on regulatory pathways.
“CSL’s advanced manufacturing processes are among several initiatives we continue to progress as part of an overall focus on operational efficiencies,” said CSL Limited Company Secretary Fiona Mead.
CSL expects clinical activities to begin in mid‑2027 using material manufactured at its Broadmeadows facility, with trial work to run in parallel with the previously announced expansion of its Kankakee, Illinois manufacturing site.
The company stated that more information on the duration of the clinical trials and the impact on Horizon 2’s regulatory approval timeline will be provided to investors when available.
CSL said the Horizon 2 program sits alongside broader efficiency initiatives across its plasma manufacturing network, which aim to support long‑term supply of immunoglobulin therapies and improve utilisation of collected plasma.
The group continues to invest in technology, capacity and regulatory engagement to underpin future plasma product volumes and maintain reliability of supply for patients worldwide.
At the time of reporting CSL’s share price was AUD 126.80.
