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FIRM directory of cell and gene therapies

As part of the BIA’s Memorandum of Understanding with the Forum for Innovative Regenerative Medicine (FIRM), the BIA is hosting a directory of FIRM companies who are operating in the cell and gene therapy area.

The directory has been sorted into nine sections.

• Categories - page 2

• Equipment and Devices - Page 4

• Cell Tissue supply - Page 5

• Regenerative medicine products - Page 6

• Contract service - Page 7

• Chemicals Material - Page 10

• Pharmaceutical company - Page 11

• Facilities Construction - Page 12

• Logistics support - Page 13

• Other services - Page 14

About FIRM

Here at FIRM, our objective is to establish systems to ensure that the community has safe and stable access to the benefits of research into regenerative medicine. Not only do we seek complete cures for the ills that many medical patients suffer from, but we also strive to safeguard the interest, contribute to international society, and pave the way for the commercialization of new regenerative medicine techniques with the purpose of building a social consensus on the application of such techniques. To that end, we engage in the following activities:

• Advice from an international standpoint on commercialization strategies and issues regarding regenerative medicine;

• Exchanges and tie-ups in and internationally related to regenerative medicine;

• Regenerative medicine surveys, publication of results and statistics;

• Hosting and organizing research workshops and open lectures on regenerative medicine;

• All activities incidental or related to the foregoing.

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Categories

Category Business Equipment and devices (reusable/capital) Manufacture and sales of reusable (capital) manufacturing equipment Manufacture and sales of reusable (capital) research equipment Manufacture and sales of analytical and testing equipment Manufacture and sales of tissue collection and handling equipment Other

Cell/Tissue supply Materials for pre-clinical study Materials for clinical study

Regenerative medicine products Tissue engineering Cell therapy Gene and gene modified cell therapy Immunotherapy Other

Contract service CMO (Contract manufacturing service under GMP grade (CPC) for clinical study CMO (Contract manufacturing service under GMP grade (CPC) for commercialization CRO (Contract preclinical study) CRO (Contract research and development) CRO (Contract clinical trial) Cell Banking Other

Chemicals/Materials Reagent/Medium (clinical and preclinical) Test (kit/reagent) Disposable research equipment (research grade plastic dish, etc.) Disposable production equipment (GMP grade plastic dish, etc.) Other

Pharmaceutical company Pharmaceutical company

Facilities/Construction CPC construction

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Air conditioning Other

Shipping/transport Logistics/Support Coldchain Tracking/monitoring Decision support tools and software Logistics/co-ordination Other

Other services Human resource training/dispatch Consulting-R&D Consulting - regulatory Consulting - CMC/analytical Consulting - Patent attorney Consulting - financial serivces Consulting - other Patent attorney/lawyer/accountant etc Finance/Insurance Venture capital Other

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Equipment and Devices

Manufacture Manufacture Manufacture Manufacture and sales of and sales of and sales of and sales of reusable reusable tissue Company/organisation analytical Other Website Contact details (capital) (capital) collection and testing manufacturing research and handling equipment equipment equipment equipment

CellSeed Inc. 〇 http://www.cellseed.com/index-e.html

Cyfuse Biomedical K.K. 〇 〇 https://www.cyfusebio.com/en/

Hitachi, Ltd. 〇 〇 http://www.hitachi.com/

INABATA&CO.,LTD. 〇 〇 https://www.inabata.co.jp/english/

KANEKA CORPORATION 〇 http://www.kaneka.co.jp/kaneka-e/ Kawasaki Heavy Industries,

〇 〇 〇 http://global.kawasaki.com/en/index.html Ltd.

Merck Ltd. 〇 〇 https://www.merckgroup.com/en 〇 Sales of

MICRON Inc. Medical image https://firm.or.jp/en analysis software BIOSCIENCES

〇 https://www.nichirei.co.jp/bio/english/index.html INC.

Nissan Chemical Corporation 〇 https://www.nissanchem.co.jp/eng/ NSK Ltd. 〇 〇

Olympus Corporation 〇 https://www.olympus-global.com/

PHC Corporation 〇 https://www.phchd.com/global/

SANKI Engineering Co., Ltd 〇 https://www.sanki.co.jp/en/

SCREEN Holdings Co., Ltd. 〇 〇 https://www.screen.co.jp/eng/index.html

SYSMEX CORPORATION 〇 〇 〇 http://www.sysmex.co.jp/en/index.html

TERUMO CORPORATION 〇 http://www.terumo.com/

ZIMMER BIOMET 〇 https://firm.or.jp/en

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Cell Tissue supply

Materials for Materials for Company/organisation pre-clinical Website Contact details Comments clinical study study

Cyfuse Biomedical K.K. 〇 https://www.cyfusebio.com/en/

FUJIFILM Corporation 〇 〇 http://www.fujifilm.com/ KANEKA http://www.kaneka.co.jp/kaneka- 〇 〇

CORPORATION e/

TAKARA BIO INC. 〇 http://www.takara-bio.com/

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Regenerative medicine products

Gene and gene Tissue Company/organisation Cell therapy modified cell Immunotherapy Other Website Comments engineering therapy

Asahi Kasei Corporation 〇 http://www.asahi-kasei.co.jp/asahi/en/

Astellas Pharma Inc. 〇 〇 https://www.astellas.com/en/ BrightPath Biotherapeutics Co.,

〇 〇 〇 https://www.brightpathbio.com/english/index.html Ltd.

CellSeed Inc. 〇 〇 http://www.cellseed.com/index-e.html

Cyfuse Biomedical K.K. 〇 〇 https://www.cyfusebio.com/en/

Daiichi Sankyo Co., Ltd. 〇 〇 https://www.daiichisankyo.com/

Evonik Japan Co., Ltd. 〇 https://corporate.evonik.com/en/Pages/default.aspx

FUJIFILM Corporation 〇 〇 〇 http://www.fujifilm.com/ FUJISOFT Tissue Engineering

〇 〇 http://www.fstec.co.jp/en/ Co., Ltd.

HEALIOS K.K. 〇 http://www.healios.co.jp/ Japan Tissue Engineering Co.,

〇 http://www.jpte.co.jp/english/index.html Ltd.

JCR Pharmaceuticals Co., Ltd. 〇 http://www.jcrpharm.co.jp/en/site/en/index.html

KANEKA CORPORATION 〇 http://www.kaneka.co.jp/kaneka-e/

LYMPHOTEC Inc. 〇 http://www.lymphotec.co.jp/english/ Planning Clinical Trial on Knee Cartilage licensed by Histgenics in US

MEDINET Co., Ltd. 〇 〇 https://www.medinet-inc.co.jp/english/ Planning Clinical Trial on DC Therapy for ATL cooperating with Kyushu Cancer Center

Metcela Inc. 〇 〇 https://www.metcela.com/en/

Novartis Pharma K.K. 〇 https://www.novartis.co.uk/ Otsuka Pharmaceutical Factory,

〇 https://www.otsukakj.jp/en/ Inc.

ROHTO Pharmaceutical Co., Ltd. 〇 https://www.rohto.co.jp/global/ Sumitomo Dainippon Pharma

〇 https://www.ds-pharma.com/ Co., Ltd. 〇

TAKARA BIO INC. 〇 http://www.takara-bio.com/ oncolytic virus Takeda Pharmaceutical Company

〇 〇 https://www.takeda.com/ Limited

Teijin Limited 〇 〇 〇 https://www.teijin.com/

TERUMO CORPORATION 〇 http://www.terumo.com/

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Contract service

CMO CMO (Contract (Contract manufacturing CRO manufacturin CRO CRO service under (Contract Cell Company/organisatio g service (Contract (Contrac GMP grade research and Bankin Other Website Comments n under GMP preclinica t clinical (CPC) for development g grade (CPC) l study) trial) commercializatio ) for clinical n study

A2 Healthcare

○ http://www.a2healthcare.com/en/ Corporation ○ manufacture and development of

API Co.,Ltd. biopharmaceutica http://www.api3838.co.jp/en/index.html l drugs, diagnostic drugs and reagent

CellSeed Inc. ○ ○ http://www.cellseed.com/index-e.html

CMIC Co., Ltd. ○ ○ ○ ○ ○ ○ https://www.cmicgroup.com/e/ Cyfuse Biomedical

○ https://www.cyfusebio.com/en/ K.K. Evonik Japan Co., https://corporate.evonik.com/en/Pages/default.asp ○ ○

Ltd. x FUJISOFT Tissue

○ ○ ○ ○ ○ http://www.fstec.co.jp/en/ Engineering Co., Ltd.

iPS PORTAL, Inc. ○ http://ipsportal.com/en/ IQVIA Services Japan

○ https://www.iqvia.com/ K.K. Japan Tissue

○ ○ ○ ○ ○ http://www.jpte.co.jp/english/index.html Engineering Co., Ltd. KANEKA

○ ○ http://www.kaneka.co.jp/kaneka-e/ CORPORATION

LYMPHOTEC Inc. ○ ○ http://www.lymphotec.co.jp/english/ For Immuno cell therapy

MEDINET Co., Ltd. ○ 〇 https://www.medinet-inc.co.jp/english/ For other type of cells, other than immuno cells ○ Analysis and

MICRON Inc. ○ http://micron-kobe.com/english/ interpretation of medical images

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Nikon CeLL

○ ○ ○ http://www.ave.nikon.co.jp/ncli/en/ innovation Co. Ltd. ○ PAREXEL In country

○ https://www.parexel.com/ International Inc. Clinical Care- taker POC Clinical

○ ○ ○ https://www.poccr.com/en/ Research Inc. ROHTO

Pharmaceutical Co., ○ https://www.rohto.co.jp/global/ Ltd. SYSMEX

○ http://www.sysmex.co.jp/en/index.html CORPORATION ○

TAKARA BIO INC. ○ ○ ○ ○ ○ viral vector http://www.takara-bio.com/ production

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Chemicals Materials

Disposabl Disposabl e e research production Reagent/Mediu Test equipment equipment Company/organisation m (clinical and (kit/reagent (research Other Website Contact details (GMP preclinical) ) grade grade plastic plastic dish, etc.) dish, etc.)

AJINOMOTO CO., INC. 〇 https://www.ajinomoto.com/en/

API Co.,Ltd. 〇 http://www.api3838.co.jp/en/index.html https://firm.or.jp/e Cell Science & Technology Institute Inc. 〇

n

CellSeed Inc. 〇 〇 http://www.cellseed.com/index-e.html

Dai Nippon Printing Co., Ltd. 〇 〇 http://www.dnp.co.jp/eng/

Dojindo Laboratories 〇 https://www.dojindo.com/

Evonik Japan Co., Ltd. 〇 https://corporate.evonik.com/en/Pages/default.aspx

FUJIFILM Corporation 〇 〇 http://www.fujifilm.com/

FUJIFILM Wako Pure Chemical Corporation 〇 〇 http://ffwk.fujifilm.co.jp/en/index.html

INABATA&CO.,LTD. 〇 〇 〇 〇 〇 https://www.inabata.co.jp/english/

JAPAN BIOMEDICAL CO., LTD. 〇 https://www.japan-biomedical.jp/

KANEKA CORPORATION 〇 http://www.kaneka.co.jp/kaneka-e/

KANTO CHEMICAL CO., INC. 〇 〇 https://www.kanto.co.jp/english/index.html

KOKEN CO., LTD. 〇 〇 https://atelocollagen.com/en/

KURARAY CO., LTD. 〇 http://www.kuraray.com/

Kyokuto Pharmaceutical Industrial Co., Ltd. 〇 〇 https://ssl.kyokutoseiyaku.co.jp/english/index.html

LYMPHOTEC Inc. 〇 〇 〇 http://www.lymphotec.co.jp/english/

MITSUBISHI GAS CHEMICAL COMPANY,INC. 〇 https://www.mgc.co.jp/eng/index.html

NICHIREI BIOSCIENCES INC. 〇 〇 https://www.nichirei.co.jp/bio/english/index.html

Nissan Chemical Corporation 〇 https://www.nissanchem.co.jp/eng/

SCREEN Holdings Co., Ltd. 〇 https://www.screen.co.jp/eng/index.html ○

SUMITOMO CHEMICAL Co., Ltd. agrichemical https://www.sumitomo-chem.co.jp/english/ s 〇

SYSMEX CORPORATION 〇 Medium http://www.sysmex.co.jp/en/index.html material

TAKARA BIO INC. 〇 〇 http://www.takara-bio.com/

Teijin Limited 〇 〇 https://www.teijin.com/

TERUMO CORPORATION 〇 http://www.terumo.com/

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ZENOAQ RESOURCE CO., LTD. 〇 http://www.zenoaq.jp/english/

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Pharmaceutical company

Pharmaceutical Company/organisation Website company

Alfresa Corporation ○ https://www.alfresa.com/eng/index.html

API Co.,Ltd. ○ http://www.api3838.co.jp/en/index.html

Astellas Pharma Inc. ○ https://www.astellas.com/en/

BrightPath Biotherapeutics Co., Ltd. ○ https://www.brightpathbio.com/english/index.html

CellSeed Inc. ○ http://www.cellseed.com/index-e.html

Daiichi Sankyo Co., Ltd. ○ https://www.daiichisankyo.com/

Eisai Co., Ltd. ○ https://www.eisai.com/index.html

FUJISOFT Tissue Engineering Co., Ltd. ○ http://www.fstec.co.jp/en/

JCR Pharmaceuticals Co., Ltd. ○ http://www.jcrpharm.co.jp/en/site/en/index.html

Kaken Pharmaceutical Co., Ltd. ○ http://www.kaken.co.jp/english/index.html

Nobelpharma Co., Ltd. ○ https://www.nobelpharma.co.jp/en/

Otsuka Pharmaceutical Factory, Inc. ○ https://www.otsukakj.jp/en/

Pfizer Japan Inc. ○ https://www.pfizer.com/

ROHTO Pharmaceutical Co., Ltd. ○ https://www.rohto.co.jp/global/ ○ Active

SUMITOMO CHEMICAL Co., Ltd. Pharmaceutical https://www.sumitomo-chem.co.jp/english/ Ingredients and Intermediates

Sumitomo Dainippon Pharma Co., Ltd. ○ https://www.ds-pharma.com/

TAKARA BIO INC. ○ http://www.takara-bio.com/

Takeda Pharmaceutical Company Limited ○ https://www.takeda.com/

Teijin Limited ○ https://www.teijin.com/

TERUMO CORPORATION ○ http://www.terumo.com/

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Facilities Construction

CPC Air Company/organisation Other Website construction conditioning

CHIYODA CORPORATION ○ ○ CPC https://www.chiyodacorp.com/en/ engineering

Hitachi Plant Services Co., Ltd. ○ ○ ○ http://www.hitachi.com/

Kawasaki Heavy Industries, Ltd. ○ http://global.kawasaki.com/en/index.html

SANKEN SETSUBI KOGYO CO.,LTD. ○ ○ ○ https://skk.jp/en/corporate/

SANKI Engineering Co., Ltd ○ ○ https://www.sanki.co.jp/en/

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Logistics Support

Decision support Logistics/co- Company/organisation Shipping/transport Coldchain Tracking/monitoring tools Other Website Contact details ordination and software

A2 Healthcare Corporation ○ ○ ○ http://www.a2healthcare.com/en/

Alfresa Corporation ○ ○ ○ ○ ○ https://www.alfresa.com/eng/index.html https://www.logistics.dhl/jp-en/home/our- DHL Supply Chain Ltd. ○ ○ ○ ○ divisions/supply-chain/sectors-overview/life-

sciences-and-healthcare.html

JTB Communication Design, Inc. ○ https://www.jtbcom.co.jp/en/

KANEKA CORPORATION ○ http://www.kaneka.co.jp/kaneka-e/

MEDINET Co., Ltd. ○ ○ https://www.medinet-inc.co.jp/english/ MITSUBISHI GAS CHEMICAL

○ https://www.mgc.co.jp/eng/index.html COMPANY,INC.

NISSIN CORPORATION ○ ○ https://www.nissin-tw.co.jp/english/index.html

PAREXEL International Inc. ○ ○ https://www.parexel.com/

TOMITA PHARMACEUTICAL CO., LTD. ○ https://firm.or.jp/en

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Other services

Human Consultin Consultin Consulting - Consultin Patent Finance/ Ventur Company/organisati resource Consultin g - g - Consultin Othe CMC/analytic g - Patent attorney/lawyer/account Insuranc e Website on training/dispatc g-R&D regulator financial g - other r al attorney ant etc e capital h y serivces A2 Healthcare

○ ○ ○ http://www.a2healthcare.com/en/ Corporation https://www.cellseed.com/index- CellSeed Inc. ○ ○

e.html

CMIC Co., Ltd. ○ ○ https://www.cmicgroup.com/e/ FUJISOFT Tissue

Engineering Co., ○ ○ http://www.fstec.co.jp/en/ Ltd.

Hitachi, Ltd. ○ http://www.hitachi.com/

iPS PORTAL, Inc. ○ ○ http://ipsportal.com/en/ IQVIA Services

○ ○ ○ https://www.iqvia.com/ Japan K.K. Japan Tissue http://www.jpte.co.jp/english/index.h Engineering Co., ○ ○ Ltd. tml JTB Communication

○ https://www.jtbcom.co.jp/en/ Design, Inc.

LYMPHOTEC Inc. ○ ○ ○ http://www.lymphotec.co.jp/english/ https://www.medinet- MEDINET Co., Ltd. ○

inc.co.jp/english/ Sumitomo https://www.ms- Insurance Company, ○ Limited ins.com/english/index.html PAREXEL

○ ○ https://www.parexel.com/ International Inc. POC Clinical

○ ○ ○ ○ ○ ○ ○ https://www.poccr.com/en/ Research Inc.

Seed Planning, Inc. ○ ○ http://www.seedplanning.co.jp/en/

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