BioPharma, Pharma

AstraZeneca Plans $1.5B Manufacturing Site for Global Production of ADC Cancer Drugs

The Singapore manufacturing site will be AstraZeneca’s first facility capable of handling all steps of antibody drug conjugate production. AstraZeneca aims to open the facility in 2029.

Antibody drug conjugates have fast become a big piece of AstraZeneca’s revenue growth. The drugmaker is taking steps to ensure it has the production capacity to meet market demand for these cancer drugs, revealing plans for a $1.5 billion manufacturing site in Singapore to support its global supply of ADC medicines.

Construction of the ADC manufacturing facility will receive support from the Singapore Economic Development Board, AstraZeneca said Monday. The company expects to begin design and construction of the facility by the end of this year. Construction of a new drug manufacturing site and receiving the regulatory approvals for commercial production can take several years. AstraZeneca aims to open its new site for ADC production in 2029.

An ADC is a cancer therapy made up of three components: a targeting antibody, a chemotherapy payload, and a chemical linker that join the two together. Right now, AstraZeneca’s ADC production is handled at multiple sites responsible for steps that include antibody production, synthesis of the chemotherapy and chemical linker, and the conjugation of drug and linker to the antibody. The final step is fill and finish manufacturing in which vials are filled and packaged for distribution.

AstraZeneca says the planned Singapore facility will be its first end-to-end ADC production site that incorporates all manufacturing steps at commercial scale. In a prepared statement, AstraZeneca CEO Pascal Soriot said Singapore is one of the world’s most attractive countries for investment due to its reputation for excellence in complex manufacturing.

AstraZeneca’s ADC lineup is led by Enhertu, a therapy developed in partnership with Daiichi Sankyo. The drug won its initial FDA approval in 2019 for HER2-positive breast cancer. Its approved use in that type of cancer now spans more than 55 countries. The drug has also landed additional approvals in gastric cancer, HER2-low breast cancer, and lung cancer.

Enhertu achieved blockbuster status in 2023, accounting for $1.28 billion in revenue, a 113% increase over sales in the prior year, according to AstraZeneca’s financial reports. The drug continues to find more applications. Last month, the FDA approved Enhertu for treating HER2-expressing solid tumors regardless of cancer type or where in the body the disease started. Beyond Enhertu, AstraZeneca says its pipeline includes six wholly owned ADCs in various stages of clinical testing as well as more ADCs in preclinical development.

The Singapore ADC site is AstraZeneca’s second big manufacturing announcement this year. In February, the drugmaker announced a $300 million investment in cell therapy manufacturing in the U.S. The new Rockville, Maryland-based site will produce cell therapies for clinical trials. It will also have the capacity to handle future commercial production of AstraZeneca cell therapies.

Photo: Christopher Furlong, Getty Images