Kyowa Kirin : Completed Construction of a Multipurpose Facility Relating to Quality Assurance (Q-TOWER) at Takasaki Plant (562KB)

Kyowa Kirin Completed Construction of a Multipurpose Facility Relating to Quality Assurance (Q-TOWER) at Takasaki Plant

Tokyo, Japan, April 7, 2023 --Kyowa Kirin Co., Ltd. (TSE: 4151, President and CEO: Masashi Miyamoto, "Kyowa Kirin") announces that it has completed the construction of a new quality building (named "Q-TOWER") at Takasaki Plant (Takasaki city, Gumma Prefecture, Plant Manager: Ryuji Nomura) and the completion ceremony was held on April 6th.

Q-TOWERis compliant with GMP regulations in Japan, United States and Europe. This facility is responsible for quality control and quality assurance in relation to the manufacturing of biopharmaceuticals and raw material quality analysis. The quality control and quality assurance functions that are currently dispersed throughout the Takasaki Plant will be consolidated to Q-TOWER with the aim of streamlining the operations, promoting communication and realizing rapid, accurate implementation. Q-TOWER will be equipped with the most advanced biopharmaceutical analysis equipment in Japan, as well as automation and labor-saving facilities. Its design complies with the latest regulations and incorporates the PCaPC construction method, which enables flexible layout designs and is able to meet future regulatory requirements. It is also designed to provide an ideal working environment that encourages employees to work healithily and creatively.

【Exterior】

【Laboratory】

【Office】

During the one-day completion ceremony, a traditional Japanese Shinto ceremony was conducted in the morning and a commemorative event was held in the afternoon. The afternoon session featured lectures regarding the latest regulatory and technical information by professors who possess extensive expertise in GMP, quality control, and quality assurance. The event offered an opportunity for employees to further deepen their knowledge and understanding of quality control and cultivate a culture of quality.

Presentation title	speaker	Affiliation
Recent topics on GMP	Shingou	Professor, Laboratory of Pharmaceutical
	Sakurai	Quality Design and GMP, Department of
		Pharmacy, Faculty of Pharmaceutical
		Sciences, Tokyo University of Science
Importance of "Kotozukuri" and	Masahiro	Professor, Department of Biotechnology,
Prospects of Cell Manufacturing	Kino-oka	Graduate School of Engineering, Osaka
		University
		Director, Research Base for Cell
		Manufacturability, TechnoArena,
		Graduate School of Engineering, Osaka
		University
Expectations for the Introduction of	Yasuhito	Specially Appointed Associate Professor,
Rapid Microbiological Testing Methods	Ikematsu	Graduate School of Engineering, Osaka
for better Improvement of Quality		University,
Assurance and Control		Director, Regenerative Medicine
-The concept of microbiological control		Corporative Research Center, Hitachi
by PIC/S GMP and revision in JP -		Plant Services, Ltd.

Half a century with "GMP and Asepsis"

Tsuguo Sasaki

Guest Professor, Graduate School of

Engineering, Osaka University

GMP Technical Advisor

Hiroki Takamatsu, Executive Officer, Vice President, Head of Quality Division of Kyowa Kirin commented " At a pharmaceutical company, quality is the responsibility of every employee. A robust quality and sound compliance culture is the fountain of trust from stakeholders such as our patients, healthcare professionals and regulatory authorities. By improving the efficiency and quality of operation levels related to quality control and quality assurance with Q-TOWER, we will establish an even stricter quality control system to ensure a stable supply of our safe, high-quality pharmaceuticals globally. In addition, as the tallest building in Takasaki plant, I believe Q-TOWER will be a symbol of trust and unity with the community. This will also help contribute to the happiness of patients and their families around the world."

The Kyowa Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.

【Building overview】

Name	Q-TOWER
Construction	Earthquake-resistant PCaPC structure with 1 underground floor and 7
method / size	aboveground floors; Total floor space: Approx. 12,630 ㎡
Investment	About 14.0 billion JPY
amount
Functions	Analysis and quality assurance for biopharmaceuticals
Design /	PLANUS INC. / TAISEI CORPORATION
Construction
Completion	Dec 2022
Features	1）Compliant with GMP regulations in Japan, United States and Europe
	2) Biopharmaceutical facility with the most advanced analytical equipment in
	Japan