CSL to Trial Enhanced Horizon 2 Plasma Manufacturing

CSL Limited (ASX:CSL) announced it will undertake clinical trial work to confirm the efficacy and safety of immunoglobulin manufactured using its next generation Horizon 2 process. CSL described Horizon 2 as a patented, yield-enhancing technology that enables significantly greater production of immunoglobulin from the same base amount of plasma. Following its engagements with the U.S. Food & Drug Administration and the European Medicines Agency, the company said it will obtain clinical evidence to support and finalise the regulatory approval processes for Horizon 2.

CSL expects clinical activities to commence in mid-2027 using material manufactured at its Broadmeadows facility, allowing the work to be undertaken in parallel with construction of the previously announced expansion of its Kankakee, Illinois manufacturing facility. The company said its advanced manufacturing processes are among several initiatives it continues to progress as part of an overall focus on operational efficiencies, and that further information on the duration of the clinical trial work and its impact on the Horizon 2 regulatory approval process will be provided to investors when available.