Sterling Pharma Solutions, a global contract development and manufacturing organization, and Soligenix, a late-stage biopharmaceutical company focused on developing products to treat rare diseases, entered an agreement for Sterling to manufacture a GMP-quality synthetic hypericin developed by Soligenix, for its oncology drug, HyBryte, for clinical trials.
 
Process development of the synthetic hypericin is currently underway at Sterling’s Germantown, WI facility ahead of clinical-scale GMP manufacturing, which is expected to occur in late 2024. The synthesis involves a specialized photocatalyzed intramolecular cyclisation, and together, the parties have designed a customized flow reactor for this novel process step. 
 
The flow reactor unit is being engineered and fabricated by the German company, Peschl Ultraviolet, and contains six interchangeable flow cell chambers, which can be run in series or parallel, with independent temperature controls. It also includes multi-channel valves to enable in-line process analytical testing, as well as oscillating cleaning cycles, and will be further integrated with continuous distillation capabilities to isolate the product post-reaction. This specialized reactor has the potential to accelerate the manufacturing process, as well as improve scale-up to support the commercialization of HyBryte.
 
“We are pleased to be working with Sterling Pharma Solutions as we expand our synthetic hypericin manufacturing capabilities, with the ultimate goals of scaling up the process and reducing our cost of goods,” said Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. “We look forward to collaborating with Sterling and advancing our topical hypericin clinical programs towards worldwide commercialization.”
 
“The chemistry is reliant upon flow processing to achieve the necessary photointensity for the reaction, and we have been working alongside Soligenix to design the optimal reactor that is efficient, scalable and flexible,” said Adam Kujath, Site Head at Sterling Pharma Solutions’ Germantown facility. “Our team at Germantown has strong experience with method and process development for continuous flow chemistry, as well as the necessary analytical and regulatory services to support successful manufacturing for clinical trial and commercial supply.”