Singota Solutions has been selected to collaborate with Noveome Biotherapeutics to manufacture the ST266 investigational drug product, a biologic being evaluated in clinical studies for its potential treatment of the severe inflammatory reaction known as Cytokine Release Syndrome (CRS), also known as the Cytokine Storm, observed in COVID-19 patients.
 
Singota specializes in small batch aseptic filling of high-value injectable products into vial, syringe, and cartridge formats using the robotic Vanrx SA25 Aseptic Filling Workcell. Singota will manufacture Noveome’s ST266 to be used for IV infusion in Phase I and II clinical trials. In preclinical and clinical studies, ST266 has demonstrated significant anti-inflammatory activity, which could potentially be lifesaving for patients experiencing the often-fatal CRS, a severe and systemic complication of COVID-19 that causes multi-organ damage, especially to the lungs.
 
“We commit to working quickly, yet carefully to get our clients’ products out to patients,” said Laura Englander, senior business development and marketing manager, Singota. “Noveome has been a great partner for Singota. They have moved swiftly on the front-end, entrusting us to excel at our promise of adhering to their tight timeline to get this critical product ready for their patients.”
 
Singota will manufacture 30 mL vial fills of ST266 in June. This timeline helps Noveome in its accelerated efforts to treat patients in the clinic, which they are prepared to initiate immediately should the FDA approve its requested authorization to proceed with dosing.
 
Kevin McCracken, chief operating officer, Noveome Biotherapeutics, said, “Noveome is aggressively pursuing our investigational drug ST266 as an important therapeutic in the treatment of patients experiencing one of the most serious and life-threatening conditions brought about by COVID-19 infection. Singota’s application of isolators paired with single-use technologies uniquely positions them to establish GMP manufacturing in weeks as opposed to what would typically take several months. In addition to this enabling technology, the response and flexibility of the team at Singota has been exceptional in the rapid establishment of this collaboration.”