OR WAIT null SECS
A new GMP facility in Raleigh, NC, and a starting materials facility in Paris, France, give Cellectis end-to-end, in-house manufacturing capacity for its UCART product candidates.
Cellectis, an international, clinical-stage gene editing company, recently opened a manufacturing facility in Raleigh, NC. The new, 82,000-ft2 good manufacturing practice (GMP) facility is purpose-built for manufacturing allogeneic, universal chimeric antigen receptor T-cell (UCART) immunotherapies for oncology. UCART products are manufactured using the T-cells of a healthy donor to make off-the-shelf and ready-to-use gene-edited CAR T-cells. T-cells from one donor, used in one manufacturing batch of UCART, can make hundreds of doses of product, the company reports.
The company’s 14,000-ft2 GMP facility in Paris, France was opened in 2020 and makes clinical and commercial critical starting materials including plasma DNA, messenger RNA (mRNA), and viral vectors that are used in UCART manufacturing. The two facilities give the company end-to-end in-house manufacturing capabilities for GMP manufacturing of all critical starting materials and cell products for clinical studies and, eventually, commercial distribution.
The newly opened facility in Raleigh, NC, includes ambient GMP warehousing and cold-storage space, cryogenic storage for incoming white blood cells and for final products, manufacturing spaces, quality control laboratories, utility and maintenance areas, and office areas. Two UCART manufacturing suites each hold a custom designed, four-chamber isolator that encloses all parts of the manufacturing process, including Cellectis’ proprietary electroporation system that enables its TALEN gene editing technology.
“The manufacturing process includes manual steps that operators perform through glove ports in the isolators, which create a Grade A environment,” explains Steve Doares, senior vice-president of US manufacturing and Raleigh site head at Cellectis. “UCART processing can’t use in-process or terminal filter sterilization, so we must maintain an aseptic state from beginning to end. Rather than putting the process equipment inside biosafety cabinets, we chose to completely enclose them in isolators to give the best possible assurance of product quality for the patient.”
A separate filling suite contains a single-chamber isolator with a robotic filling system. Vials are filled, inspected, labeled, and frozen under highly controlled conditions. Doares notes that the manufacturing process uses single-use systems, which he says are most suitable for the scale of this process.
“Having control over the entire development, manufacturing, and production process helps eliminate setbacks in the product development timeline that could hinder delivery of medicines to patients, which is an issue biotech companies have struggled with during the COVID-19 pandemic,” notes Doares.