- Establishing setup for stable global supply and accelerating development and commercialization of new drugs -

TOKYO, January 25, 2021 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced that construction of new manufacturing lines for aseptic drug products utilizing new modalities and technologies has commenced at Yaizu Technology Center of Astellas Pharma Tech Co., Ltd., a production subsidiary of Astellas.

Astellas will expand manufacturing capabilities for aseptic drug products, to reinforce stable production for global supply, and to accelerate the development and commercialization of new drugs by the new lines. The Yaizu Technology Center currently mainly manufactures solid preparations of both commercial drug products and clinical trial materials. The new aseptic drug product manufacturing lines will be newly installed for commercial antibody drugs and clinical trial materials in the existing buildings. The construction of the commercial production line for antibody drugs has started today, and the construction of the manufacturing line for clinical trial materials is scheduled to begin in July 2021. The total cost of construction is approximately ¥ 18 billion.

Astellas is developing new drugs utilizing new modalities and technologies based on its Focus Area approach. These new lines for aseptic drug products allow flexibility to manufacture not only antibodies, but also new modalities that require high technology in the future with some modification of the facility. With these new production lines, Astellas aims to improve its own manufacturing capabilities and strengthen its seamless and stable manufacturing system from development to commercialization phases.

As announced on November 11, 2020 (https://www.astellas.com/jp/en/news/22971), Astellas will absorb and merge Astellas Pharma Tech Co., Ltd. by April 1, 2022, aiming to accelerate the fusion of process development and production technology of the two companies.

These capital expenditures will have no impact on the financial forecasts of the current fiscal year ending March 31, 2021.

 

Click below for a copy of the full press release