Sterling Partners With Soligenix To Pioneer New Treatments In Medicine

Sterling Pharma Solutions, a leading global contract development and manufacturing organization, has partnered with Soligenix, a biopharmaceutical company dedicated to developing treatments for rare diseases with significant unmet medical needs. This collaboration will enable Sterling to produce GMP-quality synthetic hypericin, a key component for Soligenix's oncology drug, HyBryte™, currently in clinical trials.

Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix, mentioned “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. We look forward to collaborating with Sterling and advancing our topical hypericin clinical programmes towards worldwide commercialisation.”

Sterling’s Germantown, Wisconsin facility is currently developing the synthetic hypericin process, with clinical-scale GMP manufacturing expected to begin in late 2024. The synthesis utilizes a unique photocatalyzed intramolecular cyclization, supported by a custom flow reactor designed in collaboration with Peschl Ultraviolet. This reactor features six interchangeable flow cell chambers with independent temperature controls and is equipped for in-line analytical testing and cleaning cycles. Its design aims to speed up manufacturing and enhance scalability for the commercialization of HyBryte™.

In addition to flow synthesis, Sterling’s 210,000-square-foot facility in Germantown boasts expertise in high-potency capabilities and the synthesis of antibody-drug conjugate toxin linkers. The facility is fully certified for handling controlled substances and has a proven track record of delivering comprehensive development and manufacturing services across all stages of the molecule lifecycle, including commercial production.

“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. 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 trials and commercial supply,” stated Adam Kujath, Site Head at Sterling Pharma Solutions’ Germantown facility.