Centralised versus decentralised manufacturing and the delivery of healthcare products: A United Kingdom exemplar

Harrison, Richard P.; Rafiq, Qasim A.; Medcalf, Nick

doi:10.1016/j.jcyt.2018.05.003

Cited by 28 publications

(21 citation statements)

References 31 publications

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“…47 Manufacturing challenges in the ATMP pipeline The issue of centralised versus small-scale/hospital manufacturing has been discussed elsewhere. [254][255][256] However, in both cases, the production of patient-specific cell therapies presents unique challenges not seen in the manufacture of pharmaceuticals or biologicals.…”

Section: Challenges In Delivering Personalised Atmpsmentioning

confidence: 99%

Promises and challenges of adoptive T-cell therapies for solid tumours

et al. 2021

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Cancer is a leading cause of death worldwide and, despite new targeted therapies and immunotherapies, many patients with advanced-stage- or high-risk cancers still die, owing to metastatic disease. Adoptive T-cell therapy, involving the autologous or allogeneic transplant of tumour-infiltrating lymphocytes or genetically modified T cells expressing novel T-cell receptors or chimeric antigen receptors, has shown promise in the treatment of cancer patients, leading to durable responses and, in some cases, cure. Technological advances in genomics, computational biology, immunology and cell manufacturing have brought the aspiration of individualised therapies for cancer patients closer to reality. This new era of cell-based individualised therapeutics challenges the traditional standards of therapeutic interventions and provides opportunities for a paradigm shift in our approach to cancer therapy. Invited speakers at a 2020 symposium discussed three areas—cancer genomics, cancer immunology and cell-therapy manufacturing—that are essential to the effective translation of T-cell therapies in the treatment of solid malignancies. Key advances have been made in understanding genetic intratumour heterogeneity, and strategies to accurately identify neoantigens, overcome T-cell exhaustion and circumvent tumour immunosuppression after cell-therapy infusion are being developed. Advances are being made in cell-manufacturing approaches that have the potential to establish cell-therapies as credible therapeutic options. T-cell therapies face many challenges but hold great promise for improving clinical outcomes for patients with solid tumours.

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Section: Challenges In Delivering Personalised Atmpsmentioning

confidence: 99%

Promises and challenges of adoptive T-cell therapies for solid tumours

et al. 2021

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“…Similarly, research and development costs and clinical site onboarding were excluded. Therefore, our results cannot be generalized to the commercial setting, where additional costs would need to be incurred in regulatory affairs and intellectual property management, 11,15,18 and a return on investment would be expected 17 . Validation runs have to be added as sunk costs and can be calculated as three additional products.…”

Section: Discussionmentioning

confidence: 99%

“…Additionally, questions have been raised on the process‐related efficiency of the current centralized production of the CAR‐T therapy 13‐17 . As a response, researchers proposed “on‐site” production of CAR‐T cells, an alternative made possible by recent technological improvement in production automation 13,18‐20 .…”

Section: Introductionmentioning

confidence: 99%

“…10 Additionally, questions have been raised on the processrelated efficiency of the current centralized production of the CAR-T therapy. [13][14][15][16][17] As a response, researchers proposed "on-site" production of CAR-T cells, an alternative made possible by recent technological improvement in production automation. 13,[18][19][20] Compared to the centralized mode, decentralized "in-house" production does not require shipping and handling of the leukapheresis product, which saves time and money.…”

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confidence: 99%

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Cost of decentralized CAR T‐cell production in an academic nonprofit setting

Tao

Eichmüller

Schmidt

et al. 2020

Intl Journal of Cancer

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Chimeric antigen receptor (CAR) T-cell therapy is a promising immunotherapy with high acquisition costs, and it has raised concerns about affordability and sustainability in many countries. Furthermore, the current centralized production paradigm for the T cells is less than satisfactory. Therefore, several countries are exploring alternative Tcell production modes. Our study is based on the T-cell production experience in a nonprofit setting in Germany. We first identified the work steps and main activities in the production process. Then we determined the fixed costs and variable costs. Main cost components included personnel and technician salaries, expenditure on equipment, a clean room, as well as production materials. All costs were calculated in 2018 euros and converted into U.S. dollars. For a clean room with one machine for closed and automated manufacturing installed, annual fixed costs summed up to approximately €438 098 ($584 131). The variable cost per production was roughly €34 798 ($46 397). At the maximum capacity of one machine, total cost per product would be close to €60 000 ($78 849). As shown in the scenario analysis, if three machines were to be installed in the clean room, per production cost could be as low as €45 000 (roughly $59905). If a cheaper alternative to lentivirus was used, per production total cost could be further reduced to approximately €33 000 (roughly $44309). Decentralized T-cell production might be a less costly and more efficient alternative to the current centralized production mode that requires a high acquisition cost.

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“…Such systems rely increasingly on automation and digital networks to ensure replicability of manufacturing quality across sites, while reducing delivery time of products. While offering these potential benefits, they also introduce complex organizational and regulatory challenges, especially with regards to the cybersecurity of increasingly connected digital systems (Harrison et al, 2018).…”

Section: Next Generation Manufacturingmentioning

confidence: 99%

Cyberbiosecurity in Advanced Manufacturing Models

Guttieres

Stewart

Wolfrum

et al. 2019

Front. Bioeng. Biotechnol.

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Cybersecurity for the production of safe and effective biopharmaceuticals requires the attention of multiple stakeholders, including industry, governments, and healthcare providers. Cyberbiosecurity breaches could directly impact patients, from compromised data privacy to disruptions in production that jeopardize global pandemic response. Maintaining cybersecurity in the modern economy, where advanced manufacturing technologies and digital strategies are becoming the norm, is a significant challenge. Here, we highlight vulnerabilities in present and future biomanufacturing paradigms given the dependence of this industry sector on proprietary intellectual property, cyber-physical systems, and government-regulated production environments, as well as movement toward advanced manufacturing models. Specifically, we (1) present an analysis of digital information flow in a typical biopharmaceutical manufacturing value chain; (2) consider the potential cyberbiosecurity risks that might emerge from advanced manufacturing models such as continuous and distributed systems; and (3) provide recommendations for risk mitigation. While advanced manufacturing models hold the potential for reducing costs and increasing access to more personalized therapies, the evolving landscape of the biopharmaceutical enterprise has led to growing concerns over potential cyber attacks. Gaining better foresight on potential risks is key for implementing proactive defensive principles, framing new developments, and establishing a permanent security culture that adapts to new challenges while maintaining the transparency required for regulated production of safe and effective medicines.

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Centralised versus decentralised manufacturing and the delivery of healthcare products: A United Kingdom exemplar

Cited by 28 publications

References 31 publications

Promises and challenges of adoptive T-cell therapies for solid tumours

Promises and challenges of adoptive T-cell therapies for solid tumours

Cost of decentralized CAR T‐cell production in an academic nonprofit setting

Cyberbiosecurity in Advanced Manufacturing Models

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