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Related Concept Videos

pH Scale02:41

pH Scale

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Hydronium and hydroxide ions are present both in pure water and in all aqueous solutions, and their concentrations are inversely proportional as determined by the ion product of water (Kw). The concentrations of these ions in a solution are often critical determinants of the solution’s properties and the chemical behaviors of its other solutes. Two different solutions can differ in their hydronium or hydroxide ion concentrations by a million, billion, or even trillion times. A common means of...
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Scaling01:26

Scaling

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In designing and analyzing filters, resonant circuits, or circuit analysis at large, working with standard element values like 1 ohm, 1 henry, or 1 farad can be convenient before scaling these values to more realistic figures. This approach is widely utilized by not employing realistic element values in numerous examples and problems; it simplifies mastering circuit analysis through convenient component values. The complexity of calculations is thereby reduced, with the understanding that...
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Gene Therapy00:59

Gene Therapy

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Gene therapy is a technique where a gene is inserted into a person’s cells to prevent or treat a serious disease. The added gene may be a healthy version of the gene that is mutated in the patient, or it could be a different gene that inactivates or compensates for the patient’s disease-causing gene. For example, in patients with severe combined immunodeficiency (SCID) due to a mutation in the gene for the enzyme adenosine deaminase, a functioning version of the gene can be...
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Standard Enthalpy of Formation02:37

Standard Enthalpy of Formation

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Enthalpy changes are typically tabulated for reactions in which both the reactants and products are at the same conditions. A standard state is a commonly accepted set of conditions used as a reference point for the determination of properties under other different conditions. For chemists, the IUPAC standard state refers to materials under a pressure of 1 bar and solutions at 1 M and does not specify a temperature. Many thermochemical tables list values with a standard state of 1 atm. Because...
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Standard Electrode Potentials03:02

Standard Electrode Potentials

50.3K
On comparing the reactivity of silver and lead, it is observed that the two ionic species, Ag+ (aq) and Pb2+ (aq), show a difference in their redox reactivity towards copper: the silver ion undergoes spontaneous reduction, while the lead ion does not. This relative redox activity can be easily quantified in electrochemical cells by a property called cell potential. This property is commonly known as cell voltage in electrochemistry, and it is a measure of the energy which accompanies the charge...
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Measurement: Standard Units03:38

Measurement: Standard Units

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Every measurement provides three kinds of information: the size or magnitude of the measurement (a number), a standard of comparison for the measurement (a unit), and an indication of the uncertainty of the measurement. While the number and unit are explicitly represented when a quantity is written, the uncertainty is an aspect of the errors in the measurement results.
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Generation of CAR T Cells for Adoptive Therapy in the Context of Glioblastoma Standard of Care
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Standardizing CAR-T therapy: Getting it scaled up.

Xiaofeng Dai1, Yi Mei2, Dongyan Cai3

  • 1Wuxi School of Medicine, Jiangnan University, Wuxi, China.

Biotechnology Advances
|December 14, 2018
PubMed
Summary
This summary is machine-generated.

Commercial scale production of CAR-T therapy faces challenges due to its unique heterogeneity. Standardizing seven key factors is crucial for mass-producing this personalized cancer treatment for precision medicine.

Keywords:
Ancillary reagentsChimeric antigen receptorGovernment regulationManufacturing processPost-treatment immune monitoringQuality controlSource materialsStandardizationViral vectors

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Area of Science:

  • Oncology
  • Immunotherapy
  • Biotechnology

Background:

  • Chimeric antigen receptor T cell (CAR-T) therapy shows promise for cancer treatment, with FDA approval of two products in 2017.
  • The personalized nature and complexity of CAR-T therapy currently limit its production to specialized institutions, classifying it as a niche treatment.

Purpose of the Study:

  • To review the challenges hindering the commercial-scale production of CAR-T therapy.
  • To identify key factors for achieving mass production while preserving the personalized characteristics of CAR-T therapy.

Main Methods:

  • A comprehensive review of existing literature and industry challenges related to CAR-T therapy manufacturing.
  • Analysis of factors influencing the scalability and standardization of CAR-T production processes.

Main Results:

  • CAR-T therapy's heterogeneity presents a significant barrier to widespread adoption and large-scale manufacturing.
  • The study identifies seven critical factors that need standardization to enable mass production.

Conclusions:

  • Making CAR-T therapy a cornerstone of next-generation precision medicine requires overcoming the challenge of scalable, personalized production.
  • Standardization of identified manufacturing factors is essential to unlock the full potential of CAR-T therapy for broader patient access.