TEIJIN CDMO

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  • JP

TEIJIN CDMO

  • EN
  • JP

Teijin CDMO offers Japan-based CDMO services
for cell & gene therapies
including tissue-engineered products.

"TEIJIN REGENET CO., LTD" and "Japan Tissue Engineering Co., Ltd (J-TEC)"
are Teijin group companies.

Teijin

News

News Archives

Blogs & Topics

Key considerations for unlocking Japan’s full cell & gene therapy and regenerative medicine potential
Pickup

Apr. 13. 2023

Blog

<Blog 2>Key considerations for unlocking Japan’s full cell & gene therapy and regenerative medicine potential
Japan: A Unique Opportunity for Regenerative Medicine and Cell & Gene Therapy
Pickup

Apr. 05. 2023

Blog

<Blog 1>Japan: A Unique Opportunity for Regenerative Medicine and Cell & Gene Therapy
Exhibition Schedule 2024

Apr. 26. 2024

Topics

Exhibition Schedule 2024
How to maximize chances of success when expanding your CGT&RM portfolio into Japan

Aug. 14. 2023

Blog

<Blog 5>How to maximize chances of success when expanding your CGT&RM portfolio into Japan

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Our Strengths

Contract Manufacturing Organization (CMO) services with GMP-compliant facilities in Japan

  • We offer cell and gene therapy CDMO services from product design to production for clinical trials and for commercial use, with a proven track record of over 170 contract manufacture projects.
  • Wealth of experience in technology transfer and commercial production, successfully supplying cell and gene therapy products to over 2,500 patients.
  • Our team is well-trained and experienced in cell culture technology for a wide variety of cell types, including immune cells, stem cells, somatic cells, and gene transfer vectors.
  • Well-established and secure information management system, segmenting individuals and areas by projects to ensure information integrity and confidentiality.

Contract Development Organization (CDO) services with proven launch track-record in Japan

  • Extensive collaboration with our customers to define product standards and quality control methods in cell and gene therapy that can be applied for approval.
  • We offer consultations and expertise on pharmaceutical affairs and regulatory science strategy.

Regulatory application advisory

  • Experienced in Japanese regulations governing cell and gene therapy. We have 5 proprietary regenerative medicines on the Japanese market, including Japan’s first and second home-grown regenerative medicines, and have been working with the regulatory authorities to establish Japan’s regenerative medicine industry.
over170
benefiting over 2500

Track Record of over 170 Contract Manufacturing Projects

Item No. of contract manufacturing projects

Product development related

Technology transfers, trial culture, non-clinical studies, analytical method validation, preparation of SOPs and other documents, etc.

 84

Pharmaceutical/regulatory affairs related

PMDA consultations (pre-consultations, face-to-face advice), compliance with Act on the Safety of Regenerative Medicine

 27

Manufacture and quality related

 27

Clinical development related

Clinical trial protocol outlines, statistical analysis, data management, preparation of clinical study reports, etc.

 18

facilities related

Consulting on the design and operation of manufacturing facilities, etc.

 7

Other

Sales support, equipment installation, cell storage, etc.

 18

J-TEC performance as of December, 2022

Our Manufacturing Expertise in the field of Cell and Gene Therapy Spans a Variety of Cell Types and Vectors
(Below are representative examples)

Immune cells T-cells (CAR-T cells, etc.), dendritic cells, lymphocytes, monocytes
Stem cells Mesenchymal stem cells (derived from bone marrow, adipose tissue, and synovium), iPS cells (iPS cell-derived retinal pigment epithelial cells, iPS cell-derived intestinal epithelial cells, etc.)
Somatic cells Epithelial cells, pigment cells, chondrocytes
Vectors Lentiviruses, retroviruses, plasmids

CDMO Service from Product Design to Commercial Production

Project Development Consulting

  • Development planning
  • PMDA consultation / preparation of document

Design of Product Specification

  • Setting quality standards and safety of raw materials
  • Development of manufacturing process
  • Standard setting
  • Construction of transportation method

Manufacturing of Development Products for Clinical Trials and Commercialisation

  • Construction and operation of production system
  • Quality control testing
chart

Teijin Group’s CDMO Facilities

TEIJIN REGENET CO., LTD

Iwakuni Factory
〈Iwakuni, Yamaguchi〉(Operational from 2024)

Iwakuni Factory
  • GMP clinical and commercial manufacturing capabilities
  • Facility area: 2,400 m² (21,000 sq. ft.)
  • 3 to 6 lines in parallel
TEIJIN REGENET CO., LTD

Kashiwa-no-ha Facility
〈Kashiwa, Chiba〉(Started operation since Feb 2024)

Kashiwa-no-ha Facility
  • GMP clinical manufacturing capabilities
  • Facility area: 800 m² (8,600 sq. ft.)
J-TEC

J-TEC
〈Gamagori, Aichi〉(Started production in 1999)

Existing CDMO Center
  • GMP clinical and commercial manufacturing capabilities (J-TEC Headquarters)
  • Facility area: 5,500 m² (59,000 sq. ft.)

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