Allogeneic Cell Therapy Bioprocess Economics and Optimization: Downstream Processing Decisions

Hassan, Sally; Simaria, Ana S.; Varadaraju, Hemanthram; Gupta, Sujata; Warren, Kim; Farid, Suzanne S.

doi:10.2217/rme.15.29

Cited by 64 publications

(62 citation statements)

References 10 publications

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“…For example, the economics of allogeneic expansion for pluripotent stem cells (iPSCs and ESCs) have been recently modeled and described both for the upstream [58] as well as for the subsequent downstream operations [59]. This is not yet clearly addressed in the case of autologous large-scale expansion, where most likely a generic solution does not exist and optimal solutions will be case specific, based on inherent cell or donor properties as well as practical limitations (e.g.…”

Section: Considering Cost-effectiveness During Bioprocess Designmentioning

confidence: 99%

Bioprocess engineering strategies for autologous human MSC-based therapies: one size does not fit all

Papantoniou¹,

Lambrechts²,

Aerts³

2017

Cell Gene Therapy Insights

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Section: Considering Cost-effectiveness During Bioprocess Designmentioning

confidence: 99%

Bioprocess engineering strategies for autologous human MSC-based therapies: one size does not fit all

Papantoniou¹,

Lambrechts²,

Aerts³

2017

Cell Gene Therapy Insights

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“…Impurities must be reduced to levels below 1 ppm. The system should be closed, automated and scalable [62].…”

Section: Cell Separation Clarification and Concentrationmentioning

confidence: 99%

“…TFF combined with negative mode chromatography may therefore represent the beginning of a new generation of downstream processes for hMSCs that can be improved further by the investigation of novel adsorbents [106]. The cost of large-scale separation, clarification and concentration could be reduced fluidized bed centrifugation [62], whereas TFF would be more appropriate for smaller lots. The raw materials and detailed process parameters must always be chosen according to the cell line, media, microcarrier and expansion process.…”

Section: Separation Clarification and Concentrationmentioning

confidence: 99%

The Challenge of Human Mesenchymal Stromal Cell Expansion: Current and Prospective Answers

Elseberg¹,

Leber²,

Weidner³

et al. 2017

New Insights Into Cell Culture Technology

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In the field of cell therapy, allogenic human mesenchymal stromal cells (hMSCs) are often used in clinical trials, creating a demand for cell mass production using efficient dynamic bioreactor systems. As an advanced therapy medicinal product (ATMP), such cells should meet certain special requirements, including product specifications requiring a production process compatible with good manufacturing practice (GMP). The development of processes in which the cells are the product therefore remains a significant challenge. This chapter describes the requirements at different steps in the upstream and downstream phases of such dynamic processes. Potential solutions are presented and future prospects are discussed, including the selection of media and carriers for the strictly adherent growing cells, allowing efficient cell adhesion and detachment. Strategies for dynamic cultivation in bioreactors are described in detail for fixed-bed and stirred-tank reactors based on GMP requirements and the integration of process analytical technology (PAT). Following cell harvest, separation and purification, the formulation and storage of the product are also described. Finally, the chapter covers important cell quality characteristics necessary for the approval of ATMPs.

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“…[4][5][6][7]. This makes the benefits of Industry 4.0 with its vision of a self-organising factory less obvious for the biopharmaceutical industry.…”

Section: Industry 40 In the Biopharmaceutical Industrymentioning

confidence: 99%

Industry 4.0: a vision for personalized medicine supply chains?

Branke¹,

Farid²,

Shah³

2016

Cell and Gene Therapy Insights

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Industry 4.0 foresees a digital transformation of manufacturing resulting in smart factories and supply chains. At the heart of the concept lies the vision of interconnected materials, goods and machines, where goods find their way through the factory and the supply chain to the customer in a self-organised manner. Industry 4.0 is gaining traction in high value manufacturing sectors. This perspective paper explores what this technology-driven vision has to offer for the biopharmaceutical industry, and in particular cell and gene therapies.

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Allogeneic Cell Therapy Bioprocess Economics and Optimization: Downstream Processing Decisions

Abstract: This analysis can facilitate early decision-making during process development.

Cited by 64 publications

References 10 publications

Bioprocess engineering strategies for autologous human MSC-based therapies: one size does not fit all

Bioprocess engineering strategies for autologous human MSC-based therapies: one size does not fit all

The Challenge of Human Mesenchymal Stromal Cell Expansion: Current and Prospective Answers

Industry 4.0: a vision for personalized medicine supply chains?

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