Cellular therapies manufacturing plant
Cellectis is building a new facility named Innovative Manufacturing Plant for Allogeneic Cellular Therapies (IMPACT) in Raleigh, North Carolina, US.
The plant is being developed with an estimated investment of $68.6m to improve the company’s production capabilities. It will provide allogeneic chimeric antigen receptor (CAR) T-cell products called Universal Chimeric Antigen Receptor T-cells (UCART).
The new cellular therapies manufacturing facility was announced in March 2019 and is expected to be completed by 2021. It will generate approximately 200 new jobs.
Cellectis’ new cellular therapies manufacturing facility will be developed in Sumner Business Park at 2500-2540 Sumner Boulevard in North Raleigh, North Carolina. The company has leased the property through its subsidiary Cellectis Biologics.
Spread across 83.5 acres, the business park is located on Old Wake Forest Road between US Route 1 and Interstate 540 Interchange Outer Loop. It has parking areas and buildings with brick and glass fronts.
Raleigh was selected due to strong support from the local government and its amicable attitude towards innovative companies.
Cellectis’ IMPACT facility will be a 82,000ft² state-of-the-art, good manufacturing practices (GMP) compliant manufacturing facility for the development of UCART products at clinical and commercial-scale.
The company currently manufactures UCART for clinical trials, as well as starting materials through contract manufacturing organisations MolMed and CellForCure.
The manufacturing plant will follow GMP guidelines according to the Food and Drug Administration (FDA) and European Medicines Agency (EMA). It will be equipped to support future regulatory approvals.
Cellectis’ UCART products are allogeneic CAR T-cells developed using the company’s gene-editing platform TALEN® and the company’s proprietary PulseAgile electroporation technologies.
A UCART product with modified attributes targets selective tumour antigens and harnesses the immune system’s ability to target cancer cells in the body.
TALEN® allows for precise and targeted modification of a gene and engineers it to a product with safer and more compatible features. PulseAgile electroporation technologies are used to deliver mRNA or DNA into the cells using controlled electric fields.
The UCART products are easy to use, high-yielding, and will combat the drug price issues by lowering production costs. The main UCART candidates in the company’s portfolio are UCART19, UCART123, UCART22, UCARTCS1, UCARTCLL1, ALLO-501, ALLO-715, and ALLO-819.
The North Carolina state’s support for the company’s expansion was led by the North Carolina Department of Commerce and the Economic Development Partnership of North Carolina (EDPNC). The state’s Economic Investment Committee-approved Job Development Investment Grant (JDIC) also facilitated the expansion.
The JDIC agreement will make the company eligible for potential reimbursement of up to approximately $1.99m over a period of 12 years. The agreement can also lead to a potential transfer of $666,500 into the state’s Industrial Development Fund – Utility Account.
Colliers International assisted in concluding the real estate transaction for the lease of the new manufacturing facility in March 2019.
Cellectis is involved in the development of UCART-based immunotherapies. The company is also developing a new 14,000ft² manufacturing facility in Paris named Starting Material Realization for CAR-T products (SMART).
The new French plant will manufacture and supply important starting materials for clinical trials and UCART products. The facility will be located near the company’s headquarters in Paris.
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