Process development of the synthetic hypericin is currently under way at Sterling’s Germantown, Wisconsin facility ahead of clinical-scale GMP manufacturing, which is expected to occur in late 2024.
The synthesis involves a specialised photocatalysed intramolecular cyclisation and, together, the parties have designed a customised 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 specialised reactor has the potential to not only accelerate the manufacturing process, but also improve scale-up to support the commercialisation 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,” stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix.
“We look forward to collaborating with Sterling and advancing our topical hypericin clinical programmes towards worldwide commercialisation.”
“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.”
As well as flow synthesis, Sterling’s 210,000 sqft Germantown facility additionally specialises in high potency capabilities and antibody-drug conjugate toxin linker synthesis.
It is fully certified for controlled substance handling, and has a strong history providing full development and manufacturing services to its customers throughout all phases of the molecule lifecycle, including commercial manufacture.