Manufacturing a treatment for Fibrodysplasia Ossificans Progressiva
Quotient Sciences, an integrated Contract Research, Development and Manufacturing Organisation, has extended its commercial supply partnership with Ipsen, a global biopharmaceutical company, to manufacture a treatment for Fibrodysplasia Ossificans Progressiva (FOP), an ultra-rare disease affecting under 1,000 people worldwide.
This collaboration reinforces Quoteitn Sciences’ commitment to supporting the manufacture of niche and smaller volume commercial products. Sohonos (Palovarotene), approved by the FDA in 2023, is a potent molecule requiring specialised handling and containment to protect the facility and manufacturing operators.
As part of the partnership, Ipsen has invested in new equipment at Quotient Sciences’ Boothwyn, PA facility, including a Pneumatic Closed Transfer System, which safely transfers materials without impacting blend segregation, and a Flexible Dispensing Isolator, which improves operator safety and eliminates special cleaning requirements. Quotient Sciences provides its facility, an experienced team, reliable supply capabilities, and the ability to manage global shipments, ensuring seamless delivery and operational excellence throughout the partnership.
These additions expand Quotient Sciences’ capabilities for handling and manufacturing highly potent API (HPAPI) drug molecules and products with known OELs at or below 1 µg/m³, while integrating with existing equipment.
The partnership will ensure sustained commercial supply for FOP therapy and broaden capabilities to handle multiple highly potent compounds at commercial scale, addressing critical needs in rare disease treatment.
Marlene Leuenberger, VP and general manager, Quotient Sciences, Philadelphia, said, “This significant investment in advanced containment and manufacturing technology at our Boothwyn facility underscores Quotient Sciences’ unwavering commitment to supporting patients with ultra-rare diseases. By expanding our capabilities in handling highly potent compounds, we are not only ensuring a reliable supply of critical therapies like Sohonos (Palovarotene) for the FOP community, but also reinforcing our promise to deliver flexible, high-quality solutions for our partners with specialised needs, especially for highly potent compounds.”
