Standardizing CAR-T therapy: Getting it scaled up

Xiaofeng Dai; Yi Mei; Dongyan Cai; Weidong Han

doi:10.1016/j.biotechadv.2018.12.002

Standardizing CAR-T therapy: Getting it scaled up

Xiaofeng Dai
, Yi Mei
, Dongyan Cai
, Weidong Han

Research output: Contribution to journal › Review article › peer-review

45 Scopus citations

Abstract

CAR-T therapy, grafting the specificity of a monoclonal antibody onto a T cell to target certain cancer cells, has been recognized as a promising therapeutic approach for cancer control as evidenced by the two CAR-T products proved by FDA in 2017. However, the unique heterogeneity of CAR-T therapy has restricted its production in a limited number of institutions and made it a boutique oncotherapy. By reviewing outstanding issues surrounding the commercial scale production of CAR-T therapy, we conclude that achieving mass production of CAR-T therapy without sacrificing its personalized nature is a worldwild challenge for making CAR-T a key element in the next generation of precision medicine, which can be achieved by standardizing 7 prominent factors that collectively determine the scale of CAR-T manufacturing.

Original language	English
Pages (from-to)	239-245
Number of pages	7
Journal	Biotechnology Advances
Volume	37
Issue number	1
DOIs	https://doi.org/10.1016/j.biotechadv.2018.12.002
State	Published - 1 Jan 2019
Externally published	Yes

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

Ancillary reagents
Chimeric antigen receptor
Government regulation
Manufacturing process
Post-treatment immune monitoring
Quality control
Source materials
Standardization
Viral vectors

Access to Document

10.1016/j.biotechadv.2018.12.002

Cite this

@article{d9ba96fce37540a8bd513d2d0c1294a0,

title = "Standardizing CAR-T therapy: Getting it scaled up",

abstract = "CAR-T therapy, grafting the specificity of a monoclonal antibody onto a T cell to target certain cancer cells, has been recognized as a promising therapeutic approach for cancer control as evidenced by the two CAR-T products proved by FDA in 2017. However, the unique heterogeneity of CAR-T therapy has restricted its production in a limited number of institutions and made it a boutique oncotherapy. By reviewing outstanding issues surrounding the commercial scale production of CAR-T therapy, we conclude that achieving mass production of CAR-T therapy without sacrificing its personalized nature is a worldwild challenge for making CAR-T a key element in the next generation of precision medicine, which can be achieved by standardizing 7 prominent factors that collectively determine the scale of CAR-T manufacturing.",

keywords = "Ancillary reagents, Chimeric antigen receptor, Government regulation, Manufacturing process, Post-treatment immune monitoring, Quality control, Source materials, Standardization, Viral vectors",

author = "Xiaofeng Dai and Yi Mei and Dongyan Cai and Weidong Han",

note = "Publisher Copyright: {\textcopyright} 2018 Elsevier Inc.",

year = "2019",

month = jan,

day = "1",

doi = "10.1016/j.biotechadv.2018.12.002",

language = "英语",

volume = "37",

pages = "239--245",

journal = "Biotechnology Advances",

issn = "0734-9750",

publisher = "Elsevier Inc.",

number = "1",

}

TY - JOUR

T1 - Standardizing CAR-T therapy

T2 - Getting it scaled up

AU - Dai, Xiaofeng

AU - Mei, Yi

AU - Cai, Dongyan

AU - Han, Weidong

PY - 2019/1/1

Y1 - 2019/1/1

N2 - CAR-T therapy, grafting the specificity of a monoclonal antibody onto a T cell to target certain cancer cells, has been recognized as a promising therapeutic approach for cancer control as evidenced by the two CAR-T products proved by FDA in 2017. However, the unique heterogeneity of CAR-T therapy has restricted its production in a limited number of institutions and made it a boutique oncotherapy. By reviewing outstanding issues surrounding the commercial scale production of CAR-T therapy, we conclude that achieving mass production of CAR-T therapy without sacrificing its personalized nature is a worldwild challenge for making CAR-T a key element in the next generation of precision medicine, which can be achieved by standardizing 7 prominent factors that collectively determine the scale of CAR-T manufacturing.

AB - CAR-T therapy, grafting the specificity of a monoclonal antibody onto a T cell to target certain cancer cells, has been recognized as a promising therapeutic approach for cancer control as evidenced by the two CAR-T products proved by FDA in 2017. However, the unique heterogeneity of CAR-T therapy has restricted its production in a limited number of institutions and made it a boutique oncotherapy. By reviewing outstanding issues surrounding the commercial scale production of CAR-T therapy, we conclude that achieving mass production of CAR-T therapy without sacrificing its personalized nature is a worldwild challenge for making CAR-T a key element in the next generation of precision medicine, which can be achieved by standardizing 7 prominent factors that collectively determine the scale of CAR-T manufacturing.

KW - Ancillary reagents

KW - Chimeric antigen receptor

KW - Government regulation

KW - Manufacturing process

KW - Post-treatment immune monitoring

KW - Quality control

KW - Source materials

KW - Standardization

KW - Viral vectors

UR - https://www.scopus.com/pages/publications/85058228882

U2 - 10.1016/j.biotechadv.2018.12.002

DO - 10.1016/j.biotechadv.2018.12.002

M3 - 文献综述

C2 - 30543841

AN - SCOPUS:85058228882

SN - 0734-9750

VL - 37

SP - 239

EP - 245

JO - Biotechnology Advances

JF - Biotechnology Advances

IS - 1

ER -

Standardizing CAR-T therapy: Getting it scaled up

Abstract

UN SDGs

Keywords

Access to Document

Other files and links

Fingerprint

Cite this