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 national 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 Japan 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. 1 | P a g e 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 2 | P a g e 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 3 | P a g e 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 NICHIREI 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 4 | P a g e 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 〇 〇 http://www.kaneka.co.jp/kaneka- CORPORATION e/ TAKARA BIO INC. 〇 http://www.takara-bio.com/ 5 | P a g e 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/ 6 | P a g e 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 7 | P a g e 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 8 | P a g e 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/