Soligenix, Inc. announced on July 1, 2025, the successful completion of the manufacturing process transfer for its synthetic hypericin active ingredient to Sterling Pharma Solutions in the United States. This transfer from Europe included the optimization and implementation of a commercially viable and scalable production process.
Synthetic hypericin is the active ingredient in HyBryte™ for cutaneous T-cell lymphoma (CTCL) and SGX302 for psoriasis. The successful transfer enables cGMP (current good manufacturing practice) manufacturing for ongoing clinical trials and lays the groundwork for a long-term commercial manufacturing collaboration.
President and CEO Christopher J. Schaber highlighted the production of larger quantities of cGMP synthetic hypericin and the ongoing efforts to refine the process for cost optimization and process validation. This milestone is critical for advancing the topical hypericin clinical programs toward potential worldwide commercialization.
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