Australian biotechnology firm CSL said on Wednesday it would start clinical trials to support regulatory approval for a new manufacturing process aimed at lifting immunoglobulin output from the same amount of plasma.
Details of the Clinical Trials
The company said the studies would test the safety and efficacy of immunoglobulin produced with its proprietary Horizon 2 technology after talks with the U.S. Food and Drug Administration and the European Medicines Agency.
Clinical work is expected to begin in mid-2027 using material produced at CSL’s Broadmeadows facility in Australia.
In November, the Melbourne-based firm said it would invest $1.5 billion in the United States to manufacture plasma-derived therapies, to expand its footprint over the next five years.
Original reporting: Appleton, WI News Feed (HLL/CB) — read the source article.
