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CSL to start clinical trials for new immunoglobulin manufacturing process

CSL to start clinical trials for new immunoglobulin manufacturing process

- Australian biotechnology firm CSL CSL.AX 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 .AXJO, which was up 1.1%.


(Reporting by Keshav Singh Chundawat in Bengaluru; Editing by Subhranshu Sahu)

((Keshav.singhchundawat@thomsonreuters.com))

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