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中国生物工程杂志

China Biotechnology
China Biotechnology  2020, Vol. 40 Issue (6): 106-112    DOI: 10.13523/j.cb.2001027
    
Analysis on the Development Trend of CMO/CDMOS Industry in Global Cell Therapy
MAO Kai-yun,ZHAO Ruo-chun,WANG Yue,FAN Yue-lei,JIANG Hong-bo()
Shanghai Information Center for Life Sciences, Shanghai Institute of Nutrition and Health, Chinese Academy of Sciences, Shanghai 200031, China
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Abstract  

Objective: Based on the analysis of the current situation and major enterprises of CMO/CDMOS industry in the world, this paper reveals the quality assessment problems existing in the development of CMO/CDMOS industry, and puts forward relevant suggestions for quality assessment.Methods: quantitative analysis and comparative analysis were used to reveal the development status of Immunotherapy and stem cell therapy products and CMO/CDMOS industry.Results: With the development of cell therapy industry, more and more institutions show their interest in cell therapy CMOS / cdmos industry, which is involved by means of creation, acquisition and investment. At present, 48 companies have been identified to provide contract cell or gene therapy manufacturing services.Conclusion: The development of cell therapy industry has led to the prosperity of CMO/CDMOS contract manufacturing agreement. In view of the particularity and complexity of cell therapy, it is also full of challenges to the quality assessment of cell therapy.



Key wordsCell therapy      Cell manufacture      CMO      CDMO     
Received: 12 January 2020      Published: 23 June 2020
ZTFLH:  Q819  
Corresponding Authors: Hong-bo JIANG     E-mail: hbjiang@sibs.ac.cn
Cite this article:

MAO Kai-yun,ZHAO Ruo-chun,WANG Yue,FAN Yue-lei,JIANG Hong-bo. Analysis on the Development Trend of CMO/CDMOS Industry in Global Cell Therapy. China Biotechnology, 2020, 40(6): 106-112.

URL:

https://manu60.magtech.com.cn/biotech/10.13523/j.cb.2001027     OR     https://manu60.magtech.com.cn/biotech/Y2020/V40/I6/106

Fig.1 Development status of global immunotherapy and stem cell therapy products Source: Cortellis database
承包商 顾客 产品 提供服务
Oxford Biomedical Novartis CTL-019 Commercial lentiviral vector production
Shibuya Corp Promethera Biosciences N/A Development of clinicaland commercial-scale manufacturing platform
Lentigen TxCell CAR-Treg Clinical lentiviral vector supply
Lonza Netherlands
(formerly PharmaCell)
Lion Biotechnologies Unnamed autologous cell therapies Clinical and commercial manufacture
Cellular Dynamics International Harvard Stem Cell Institute N/A Induced pluripotent stem cell production
Brammer Bio Abeona Therapeutics N/A Clinical manufacture of candidate treatment for Sanfilippo Syndrome
Table 1 Contract manufacturing agreement of cell therapy
供应商/政府部门/大学 国家 基因治疗与
病毒产品
组织和细胞
疗法
3P Biopharmaceuticals 西班牙
Advanced BioScience Laboratories, Inc.(ABL) 美国
apceth Biopharma GmbH 德国
Areta International 意大利
Austrianova Singapore Pte. Ltd 新加坡
BioNTech Innovative Manufacturing Services (Idar-Oberstein, Germany),formerly Eufets AG 德国
Biovian 芬兰
BioReliance (Merck Group) 英国
Brammer Bio 美国
CellforCure 法国
Cellin Technologies LLC 爱沙尼亚
Cellular Therapeutics Ltd 英国
Cevec Pharmaceuticals GmbH 德国
Cobra Biologics 英国
Cognate Bioservices 美国
Esperite (formerly The Cell Factory) 荷兰
Eurogentec S.A. 比利时
Fraunhofer Group 德国
Fujifilm Diosynth Biotechnologies 美国
Genibet Biopharmaceuticals 葡萄牙
Halix 荷兰
Hitachi Chemical Co., Ltd. 美国
Holostem Terapie Avanzate 意大利
IDT Biologika GmbH 德国
Japan Tissue Engineering 日本
KBI Biopharma 美国
Lonza Group 瑞士
Lonza Netherlands (Lonza; formerly PharmaCell) 荷兰
MaSThercell 比利时
Medinet 日本
Meridian Life Sciences Inc 美国
Nikon Corporation 日本
Novasep 比利时
Oxford Genetics Ltd. 英国
Paragon Bioservices, Inc 美国
Roslin Cells (formerly Roslin Cell Therapies) 英国
SAFC (Merck Group) 美国
Sanquin Blood Supply Foundation (Stichting Sanquin Bloedvoorziening) 荷兰
Takara Bio 日本
VGXI 美国
Vibalogics 德国
Vigene Biosciences, Inc 美国
WuXi AppTec 美国
Cell and Gene Therapy Catapult 英国
Cell Therapies 澳大利亚
NCI Biopharmaceutical Development Program 美国
University of North Carolina Vector Core 美国
Waisman BioManufacturing 美国
Table 2 Global provider of cell therapy and / or gene therapy manufacturing services
[1]   Mohanty R, Chowdhury C R, Arega S , et al. Car t cell therapy: a new era for cancer treatment. Oncology Reports, 2019,42(6):2183-2195.
pmid: 31578576
[2]   Sidana S, Shah N . Car t-cell therapy: is it prime time in myeloma? Blood Advances, 2019,3(21):3473-3480.
doi: 10.1182/bloodadvances.2019000370 pmid: 31714964
[3]   Sato Y, Bando H, Di Piazza M , et al. Tumorigenicity assessment of cell therapy products: The need for global consensus and points to consider. Cytotherapy, 2019,21(11):1095-1111.
doi: 10.1016/j.jcyt.2019.10.001 pmid: 31711733
[4]   Lee B, Jung, S, Hashimura, Y . Scale up of allogeneic cell therapy manufacturing in single-use bioreactors: challenges, insights and solutions. Cytotherapy, 2019,21(5):S36-S36.
[5]   Macdonald K N, Ivison S, Hippen K L , et al. Cryopreservation timing is a critical process parameter in a thymic regulatory T-cell therapy manufacturing protocol. Cytotherapy, 2019,21(12):1216-1233.
[6]   Eaker S, Armant M, Brandwein H , et al. Concise review: guidance in developing commercializable autologous/patient-specific cell therapy manufacturing. Stem Cells Translational Medicine, 2013,2(11):871-883.
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