Cost analysis of vein-to-vein CAR T-cell therapy: automated manufacturing and supply chain

Lopes, Adriana G.; Noel, Rob; Sinclair, Andrew

doi:10.18609/cgti.2020.058

Cited by 14 publications

(8 citation statements)

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“…Each integer can take a value between [0, 4] as shown in Table I. For the production modes, we consider the three levels of automation described by Lopes et al [19], namely, manual, semi-automatic, and automatic. The implications of each of them on the failure rate are described later in Section V.…”

Section: Methodsmentioning

confidence: 99%

“…For a manual production mode, between 5% and 10% of the entire demand allocated to that facility will fail and, consequently, will need to be re-produced. For semi-automatic the range is between 3% and 10% and for automatic it is between 1% and 5% [19].…”

Section: Case Studymentioning

confidence: 99%

“…For processing, the cells are transported from the hospital to an independent manufacturing facility (MF). Each MF has a manufacturing mode which is directly responsible for the duration and success rate of the ATMP process [19]. Between the hospital and the MF, there can be an intermediary cryopreservation facility (CF).…”

Section: Introductionmentioning

confidence: 99%

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Composite Facility Location Problems: A Case Study of Personalised Medicine

Avramescu

Allmendinger

López-Ibáñez

et al. 2022

2022 IEEE Conference on Computational Intelligence in Bioinformatics and Computational Biology (CIBCB)

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Facility location problems (FLPs) are one of the most studied problem classes in supply chain management. However, despite the high number of research outputs, complex FLPs with large decision spaces and multi-objective formulations remain hard to solve. In this paper we introduce a multi-objective mathematical model for the FLP in personalised medicine, and apply a multi-stage algorithmic approach to solve it. In this case, the supply chain is circular and follows an on-demand and batch specific approach where the patient is also the donor. We solve the problem in a multi-stage manner, each stage optimising a sub-space of the larger decision space. In each stage we free up more decision variables to optimise, until eventually all decision variables defining the complete problem are made available for optimisation. A variant of the NSGA-II algorithm is used as solution method to solve both the complete problem and the different problem stages. Our results suggest that the multi-stage approach is able to find better solutions when compared to an approach that is given an equivalent number of evaluations but optimises the complete problem at once.

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Section: Methodsmentioning

confidence: 99%

Section: Case Studymentioning

confidence: 99%

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Composite Facility Location Problems: A Case Study of Personalised Medicine

Avramescu

Allmendinger

López-Ibáñez

et al. 2022

2022 IEEE Conference on Computational Intelligence in Bioinformatics and Computational Biology (CIBCB)

Self Cite

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“…Finally, the cost and complexity of manufacturing CAR-T cells are significant barriers to their general use [37]. In this context, an allogeneic CAR-HTLP strategy could bypass some of those main challenges, such as immediate availability, efficient expansion, and sustained anti-tumor response.…”

Section: Gene Modification Of Human T Lymphoid Progenitors and Clinic...mentioning

confidence: 99%

Manufacturing of Human T-lymphoid Progenitors from Two Different Hematopoietic Stem Cell Sources and Perspective for New Immunotherapies

2022

Journal of Cellular Immunology

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The adaptive immune system depends on the efficient response of lymphocytes, protecting the organism from infection or malignant diseases. T-cell immunodeficiency, innate or acquired, put the patient at risk for developing opportunistic infections and cancers. We previously described a novel approach to overcome the major limitations of T-cell immunotherapy and hematopoietic stem cell transplant (HSCT) by transplanting human T-lymphoid progenitors (HTLP), with the aim to achieve shortened immune reconstitution and fully functional naïve T-cell repertoire in immunodeficient or immunocompromised patients. By complementing our DL4-based cell culture with TNFα we developed and scaledup clinical strategies involving hematopoietic stem and progenitor cells (HSPC) differentiated into T-lymphoid progenitors. We discuss here recent advances made in the characterization of different cell sources used as starting materials for T-lymphoid progenitors manufacturing, as well as gene modification of these cells, highlighting new perspectives for the development of therapeutical strategies.

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“…Despite tremendous clinical success, the high price tag commonly associated with currently approved cell and gene therapies (CGTs) continues to represent a major hurdle for global industrial translation to a widespread patient pool [1À4]. Optimization of the economic aspects of a CGT product should be a focus from the beginning of product development, as every cost decision in the early stages of the product lifecycle can significantly impact and may limit the ability to make changes to manufacturing scale, consistency and global access [5,6]. To that end, the International Society for Cell & Gene Therapy (ISCT) Product and Process Development (PPD) Subcommittee previously published a roadmap to help understand CGT product costsand thus improve patient access-through the evaluation of key process steps: tissue procurement (cost per unit of cells) and manufacturing (cost per unit of cells and cost per dose) [7].…”

Section: Introductionmentioning

confidence: 99%