|
|
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 |
|
|
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.
|
Received: 12 January 2020
Published: 23 June 2020
|
|
Corresponding Authors:
Hong-bo JIANG
E-mail: hbjiang@sibs.ac.cn
|
|
|
[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.
|
|
|
|
Viewed |
|
|
|
Full text
|
|
|
|
|
Abstract
|
|
|
|
|
Cited |
|
|
|
|
|
Shared |
|
|
|
|
|
Discussed |
|
|
|
|