Quotient Sciences has announced an extension of its commercial supply partnership with Ipsen to manufacture a treatment for fibrodysplasia ossificans progressiva (FOP), an ultra-rare genetic disorder affecting fewer than 1,000 people worldwide.
The collaboration focuses on the continued production of Sohonos (palovarotene), which received approval from the US Food and Drug Administration in 2023. The therapy is a highly potent molecule requiring advanced containment, specialised handling procedures and stringent operator safety measures during manufacturing.
As part of the expanded partnership, Ipsen has invested in new equipment at Quotient Sciences’ Boothwyn, Pennsylvania facility. The upgrades include a Pneumatic Closed Transfer System designed to enable secure material transfer without affecting blend integrity, and a Flexible Dispensing Isolator to enhance operator protection while eliminating the need for specialised cleaning processes.
These investments strengthen Quotient Sciences’ ability to manufacture highly potent active pharmaceutical ingredient (HPAPI) products with occupational exposure limits (OELs) at or below 1 µg/m³. The enhancements also integrate with existing infrastructure, supporting efficient and compliant commercial-scale production.
The partnership is expected to ensure sustained global supply of FOP therapy while expanding the facility’s capability to handle multiple highly potent compounds, addressing critical unmet needs in rare disease treatment.
Company leadership highlighted that the investment underscores a commitment to supporting patients with ultra-rare conditions. By expanding advanced containment and manufacturing technologies at the Boothwyn site, Quotient Sciences aims to provide reliable supply and flexible, high-quality solutions for partners developing specialised and smaller-volume therapies.
Quotient Sciences operates as an integrated contract research, development and manufacturing organisation, offering services across the full drug development lifecycle. Its Translational Pharmaceutics platform integrates formulation development, manufacturing and clinical testing to accelerate drug development programmes.