Company is building a raw material production facility in France and a CAR-T cell plant in North Carolina.
One of the questions pharmaceutical companies face when commercializing their products is whether to keep production in-house or rely on contract manufacturers. Biologics firms tend to retain manufacturing in-house more often than producers of small molecules.
Cellectis is following this trend. The company is building a 14,000-ft2 facility in Paris, France to produce starting materials needed for the manufacture of its allogeneic CAR-T products, which it will also manufacture internally at a site it will build in North Carolina.
According to Cellectis CEO André Choulika, establishing internal manufacturing capability is an important part of creating the company’s own supply competencies, and the autonomy, control and expertise in manufacturing operations affords a competitive advantage.
The establishment of commercial manufacturing capabilities in the United States is led by Bill Monteith, who was hired as head of U.S. manufacturing three months ago. Cellectis recently signed a lease for the site in North Carolina, where it will construct an 82,000-ft2 commercial manufacturing facility to produce its allogeneic UCART chimeric antigen receptor (CAR)-T products. The facility, which the company has named IMPACT, will house both clinical and commercial production capabilities.
Cellectis’ “off-the-shelf” CAR-T products are derived from donor T cells, which are engineered using its TALEN gene editing technology to express a CAR capable of targeting cell-surface antigens. These allogeneic products, unlike the autologous products Yescarta (axicabtagene ciloleucel) and Kymriah (tisagenlecleucel), do not require the complex logistics involved with patient-based treatments and thus may potentially cost less and enable faster treatment –– assuming the immunogenic risk can be alleviated.