The radiopharmaceutical company AdvanCell has announced it has established its US Global Headquarters in the Greater Boston area and has leased a new 128,000-square-foot facility that will serve as the company's flagship manufacturing centre in the US.
The firm said this expansion represented a significant milestone in its evolution into a US-based radiopharmaceutical company, with it now having integrated operations across both North America and Australia
AdvancCell cited the need for infrastructure to support the development and future commercialisation of ADVC001 and its Lead-212 targeted alpha therapy pipeline as the rationale for the move.
"Establishing AdvanCell’s US Global Headquarters and future manufacturing facility reinforces our commitment to US expansion and represents an important milestone in AdvanCell's strategy to build a global, vertically integrated targeted alpha therapy company," said Dr Philina Lee, CEO of AdvanCell.
As we advance ADVC001 and our broader Lead-212 pipeline, our Andover facility will be a cornerstone of our US expansion and our first internal manufacturing site in the US, providing the foundation to scale production to support future clinical and commercial demand.
"We will continue to leverage the strengths of our Australian operations — including rapid clinical translation, isotope supply capabilities and process innovation — as we advance our Lead-212 targeted alpha therapies for patients globally."
As part of its strategy to expand US manufacturing, AdvanCell said it would be collaborating with a "leading contract development and manufacturing organisation" (CDMO) to establish drug product manufacturing capabilities, in addition to fitting out and qualifying the Andover facility.
The company did not name the CDMO in its announcement, but said the approach is expected to accelerate access to US-based manufacturing capacity, supporting the Phase II enrolment of the TheraPb study in the US while it further builds its Phase III and commercial manufacturing infrastructure.
