Experts talked about a cutting-edge treatment, cell and gene therapy, regarding how the treatment is manufactured and treats patients at a videoconference held by Bio Asia-Taiwan 2021 on July.23.
CAR-T cell therapy, as one of cell and gene therapy types, is an individualized treatment designed specifically for each patient as it utilizes specifically-altered cells from patients to strengthen their immune system, Didier Dargent, Head of International Market for Cell and Gene of Novartis, told the videoconference.
Novartis was the first company obtaining a marketing approval from the US Food and Drug Administration for its CAR-T therapy, corporate data showed.
Photo courtesy of Novartis Taiwan
The CAR-T cell therapy requires collecting blood from patients and separating the blood to collect white blood cells to gain patient’s own T cells, which play an important role in human’s immune system as they recognize foreign particles in the body and fight them, Dargent said.
The T cells would be reprogrammed, or genetically engineered, with an inactive viral vector and all other necessary information to produce a CAR on their surface; with the CAR, the T cells would be transformed into CAR-T cells and be able to target certain molecules on cancer cells and destroy them, Dargent said.
In the final stage, the CAR-T cells would be infused back into the patients and have a better capability to detect and attack cancer cells, Dargent said.
As CAR-T cells could multiply, they are described as “living drugs,” and CAR-T cell therapy is viewed as the combination of cell therapy, gene therapy and immunotherapy, the data showed.
Unlike traditional pills that are produced in an one-way supply chain, sent from pharmaceutical companies’ factories to pharmacies or hospitals for the doctors’ use, CAR-T cell therapy adopts a closed-loop production, involving patients, cell processing and isolation stations, hospital team and Pharmaceutical company, Dargent said.
While only qualified treatment centers can administer CAR-T cell therapy, Novartis currently utilizes seven facilities, some being its own and some being contract manufacturing organizations, across four continents to deliver the treatment to patients in need, Dargent said.
The company had manufactured CAR-T cells for more than 5,000 patients in the world, Dargent said.
The CAR-T therapy has been approved for patients with certain blood cancers such as leukemia and lymphoma in the US, European Union, Switzerland, Canada, Australia, Japan, Singapore, Saudi Arabia, Hong Kong and South Korea, he said.
With more than 20 approved medicines in oncology, hematology and rare disease and over 30 new molecular entities in development including tapered therapy and immuno-oncology, Novartis aims to discover new ways to improve and extent people’s lives, Dargent said.
“We strive to address medical needs through reimagining medicine using our cell and gene platform,” Dargent said.
CAR-T manufacturing processes different options at every step, such as T-cell selection, T-cell activation, gene transfer, T-cell expansion and T-cell formulation, and each product has unique attributes and outcome, Dominic Wall, the Australia-based Peter MacCallum Cancer Centre’s executive director of business ventures, told the videoconference.
Therefore, the quality assurance and quality control is the key, Wall said, adding that that was why people said “process is the product.”
Though many experimental treatments that adopted the autologous CAR-T cell technology were still under phase one or two clinical trials, with only a few treatments marketed, the cell and gene therapy market is expected to grow at a compound annual growth rate of 33 percent by 2025, Wall said.
(Advertorial)
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