Sterling Pharma Solutions Announces Partnership With Soligenix

Sterling Pharma Solutions and Soligenix recently announced a partnership that will see Sterling manufacture a GMP-quality synthetic hypericin developed by Soligenix, for its oncology drug, HyBryte, in clinical trials.

Process development of the synthetic hypericin is currently underway at Sterling’s Germantown, Wisconsin 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 not only accelerate the manufacturing process, but also 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 toward 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,” added 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-sq-ft Germantown facility additionally specializes 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.

Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte (SGX301 or synthetic hypericin sodium) as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma (CTCL). With successful completion of the second Phase 3 study, regulatory approvals will be sought to support potential commercialization worldwide. Development programs in this business segment also include expansion of synthetic hypericin (SGX302) into psoriasis, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer, and (SGX945) in Behçet’s Disease.

Our Public Health Solutions business segment includes development programs for RiVax, our ricin toxin vaccine candidate, as well as our vaccine programs targeting filoviruses (such as Marburg and Ebola) and CiVax, our vaccine candidate for the prevention of COVID-19 (caused by SARS-CoV-2). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax. To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agency (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA). For more information, visit  https://www.soligenix.com.

Sterling Pharma Solutions is a global contract development and manufacturing organization (CDMO) with more than 50 years’ experience in providing small molecule API development and manufacturing services to the pharmaceutical industry, specialising in handling challenging chemistries. Sterling manages the most complex API challenges from proof-of-concept to commercial manufacture, as well as antibody-drug conjugate (ADC) research and development bioconjugation services.

Sterling has six facilities employing more than 1,350 people: its HQ in Dudley, Northumberland, UK; a chemistry services business in Newcastle upon Tyne, UK; a site in Ringaskiddy, Co. Cork, Ireland; a dedicated bioconjugation and ADCs facility in Deeside, North Wales, UK; and two sites in the US, in Cary, North Carolina and Germantown, Wisconsin. Find out more.