CSL has announced it will begin clinical trials to evaluate the safety and efficacy of immunoglobulin produced with its next-generation Horizon 2 manufacturing process.
The company said Horizon 2 is a patented, yield-enhancing technology that enables significantly greater production of immunoglobulin from the same base amount of plasma.
Following discussions with the US Food and Drug Administration and the European Medicines Agency, CSL will gather clinical evidence to support and finalise regulatory approval for Horizon 2. The company said the trials form part of a broader push to improve operational efficiencies through advanced manufacturing techniques.
CSL said it expects the clinical activities to start in mid-2027. It will use material produced at its Broadmeadows facility. Conducting the trials there will allow the clinical work to proceed in parallel with construction of the previously announced expansion of CSL’s Kankakee, Illinois, manufacturing site in the US.
The company said it will provide further information on the duration of the clinical trials and any impact on the regulatory approval timeline for Horizon 2 when that information becomes available.
