AstraZeneca Building Shanghai Production Plant to Support Cell Therapy Strategy

 

The company is establishing commercial production capabilities to fuel plans to launch autologous CAR-T cell therapies in China.

AstraZeneca has committed to building a manufacturing base in Shanghai as part of its push to become the first global drugmaker with end-to-end cell therapy capabilities in China.

The Anglo-Swedish drugmaker recently pledged to invest more than $15 billion in China by 2030. At the time, AstraZeneca said the investment would expand its capabilities for making treatments including cell therapies. The company committed to becoming the first global company with end-to-end cell therapy capabilities in China, without sharing details of the infrastructure it will build to achieve that goal.

AstraZeneca provided more information in a statement on its Chinese website Thursday. The company is building a commercial cell therapy manufacturing base in a free trade zone in Shanghai to supply CAR-T cell therapies to China and other Asian markets.

Establishing the capabilities will equip AstraZeneca to support the planned launches of autologous cell therapies, including its BCMA/CD19 dual-target candidate AZD0120. AstraZeneca acquired the therapy as part of its takeover of China’s Gracell Biotechnologies for around $1 billion upfront.

AstraZeneca started a global Phase 3 trial of AZD0120 in multiple myeloma last month. The company is running early-phase studies in lupus, multiple sclerosis and rheumatoid arthritis, establishing itself among the wave of drugmakers exploring cell therapies in autoimmune diseases. The ability of AZD0120 to destroy B cells points to the potential to treat autoimmune diseases that are resistant to existing drugs.

AZD0120 is produced from a patient’s own T cells, making manufacturing and logistics key to its commercial prospects. AstraZeneca will need to get T cells to its manufacturing facility, process them and ship the resulting therapy to the patient. Other companies have struggled with CAR-T production, with supply constraining launches and manufacturing failures affecting 18% of patients in one trial.

AstraZeneca is investing across the cell therapy supply chain to avoid the setbacks suffered by its peers. As well as setting up a commercial facility in Shanghai, the company will establish an innovation center at a science park in the city. The cell therapy center will support early-stage research, viral vector and plasmid development, analytical testing and clinical manufacturing.

Building the facilities will tighten AstraZeneca’s ties to Shanghai, where one of its global R&D centers is based. AstraZeneca has continued to invest in China while contending with challenges, including the detention of its former leader in the country and an investigation into allegations of illegal import.

The company shared details of the new Shanghai facilities alongside news that it is working with groups in China and the U.K. to set up a collaboration program. Through the program, AstraZeneca plans to pair Chinese innovation with global scientific and financial resources.

https://www.biospace.com/business/astrazeneca-building-shanghai-production-plant-to-support-cell-therapy-strategy