July 29 (Reuters) – 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.
Here are the details:
• CSL 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.
• The company said Horizon 2 is a patented process that increases yield, potentially improving manufacturing efficiency for one of its key products.
• 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.
• Shares of the company rose as much as 7.7% to A$128.670, their highest since April 29. The stock was the top gainer on the benchmark S&P/ASX 200 index, which was up 1.1%.
(Reporting by Keshav Singh Chundawat in Bengaluru; Editing by Subhranshu Sahu)
