The joint venture will build on Cincinnati Children's existing Translational Core Laboratory, which manufactures and tests services for cell and gene therapy clinical trials.
The $100m investment will create a new facility in the Cincinnati/Northern Kentucky region. This will include a new clinical laboratory, expected to cover 40,000 square feet and house three dozen sterile clean rooms. The facility will be able to support the research of more than 30 clinical trial sponsors at a time.
Around 150 jobs will be created, with the new company pledging to build on the region's growing status as a research hub. An opening date is likely to be in 2023.
Manufacturing capacity shortage
The joint venture is responding to a global shortage of manufacturing capacity, which has begun to impede development of new cell and gene therapies. In fact, the industry has less than 1% of the capacity needed to support a growing volume of clinical programs, according to CTI.
Fifteen cell and gene therapy products have been approved by global regulatory agencies, and the Alliance for Regenerative Medicine estimates 10 to 20 additional approvals per year by 2025.
"Medicine is rapidly evolving toward cell- and gene-based therapies," said Steve Davis, MD, president and CEO of Cincinnati Children's, which is one of the top three recipients of pediatric research grants from the National Institutes of Health.
"By melding the scientific expertise of Cincinnati Children's with the operational expertise of CTI, this joint venture will ensure that our community, region and the world have ready access to the most innovative and effective therapies."
Tim Schroeder, CEO and chairman of CTI, added: "We anticipate advances in cell and gene therapies to bring about medical breakthroughs with the potential to not only treat, but actually cure some rare and complex diseases – including some forms of cancer."
"CTI and Cincinnati Children's have been engaging in conversations for some time about ways to further these developments and bring new treatments to the children and adult patients looking for hope.
"This joint venture is a natural evolution of our pre-existing relationship involving clinical trials, maximizing the expertise and resources of both organizations to collaborate, innovate, and facilitate scientific developments with the potential to save lives."