Astellas Pharma has announced the construction of new research, development, and manufacturing facilities for biologic-based modalities, including antibodies and cell therapies, in Japan and Massachusetts. The facilities will produce clinical trial materials (CTM) for regenerative medicines and cell and gene therapies as well as CTM and commercial supply for antibodies.

The company plans to construct a Center for Active Ingredient for Biopharmaceuticals in Toyama, Japan, which will be capable of manufacturing antibodies for use in both CTM and commercial products in Japan, the US, and Europe while also manufacturing products that include other modalities such as cell therapy. The center, which will cost approximately 10.0 billion Yen ($88.5 million), will have four above-ground floors and total floor area of approximately 8,000 square meters. The facility will be inside the premises of Toyama Technology Center of Astellas Pharma Tech Co., Ltd., a production subsidiary of Astellas. Work will begin in November 2018 and is scheduled for completion during September 2019.

Astellas also plans to build a Center for Multimodality Clinical Trial Materials in Tsukuba, Japan for the manufacture of CTM for use in early-stage clinical trials (Phase I and Phase II) for developing cell therapies and gene therapies for patients in Japan, the US, and Europe. The total cost of the facility is approximately ¥5.0 billion ($44 million). The center will have two above-ground floors and total floor area of approximately 1,800-square-meters and will be constructed inside the company’s Tsukuba Biotechnology Research Center. Work began in September 2018 and is scheduled for completion during March 2019.

The company also plans to relocate and renovate its existing Massachusetts center, The Astellas Institute for Regenerative Medicine (AIRM), a subsidiary of Astellas and a center for the research and development of regenerative medicine and cell therapy. The center will move to a new location within the state of Massachusetts with two above-ground floors and a total floor area of 24,000 square meters. In addition, the facility will be upgraded. As a result of this relocation and renovation, Astellas says the new facility will enable it to accelerate research and development in the field of regenerative medicine and cell therapy. In addition, the company expects the enhancement of the production facilities will also make it possible to smoothly supply CTM and to meet commercial production demands. The total cost of the facility is approximately ¥14.0 billion ($123 million). Work began in September 2018 and is scheduled for completion during January 2020.

Source: Astellas Pharma