- Sterling Pharma Solutions will manufacture GMP-quality synthetic hypericin for Soligenix’s oncology drug, HyBryte, with production set for late 2024.
- A specialized flow reactor, designed in collaboration with Peschl Ultraviolet, will enhance the manufacturing process at Sterling’s Wisconsin facility.
Sterling Pharma Solutions, a global CDMO, has entered into an agreement with biopharmaceutical company Soligenix to manufacture GMP-quality synthetic hypericin for use in the latter’s oncology drug, HyBryte. The agreement focuses on producing the compound for clinical trials, with manufacturing scheduled to begin in late 2024 at Sterling’s Germantown, Wisconsin site.
The process involves a specialized photocatalyzed intramolecular cyclisation step. To optimize this, the two companies have collaborated with Peschl Ultraviolet to design a customized flow reactor. This reactor, containing six interchangeable flow cell chambers with independent temperature controls, is expected to accelerate manufacturing and improve scalability for the future commercialization of HyBryte.
According to Christopher J. Schaber, President and CEO of Soligenix, the partnership is aimed at expanding synthetic hypericin manufacturing capabilities and reducing production costs. Schaber stated, “We look forward to collaborating with Sterling and advancing our topical hypericin clinical programs towards worldwide commercialization.”
Adam Kujath, Site Head at Sterling’s Germantown facility, emphasized the importance of flow processing in achieving the necessary photointensity for the synthesis. Kujath noted the team’s expertise in continuous flow chemistry and their ability to support regulatory requirements for both clinical trial and commercial supply.
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