Addressing potential ethical issues regarding the supply of human-derived products or reagents in in vitro OECD Test Guidelines

Jacobs, Miriam N.; Versteegen, Rosemary; Treasure, Carol; Murray, Jennifer

doi:10.14573/altex.1901281

Cited by 6 publications

(8 citation statements)

References 9 publications

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“…Limited supply Universal donor -meets most HLA requirements Relies on donation Appears to have a higher proliferative capacity (Thaweesapphithak et al, 2019) Ethical issues associated with use of human-derived products (Jacobs et al, 2019) GMP grade available Potential spread of human diseases (Karnieli et al, 2017) Human platelet lysate (HPL)…”

Section: Human Originmentioning

confidence: 99%

Biological Considerations in Scaling Up Therapeutic Cell Manufacturing

et al. 2020

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Cell therapeuticsusing cells as living drugshave made advances in many areas of medicine. One of the most clinically studied cell-based therapy products is mesenchymal stromal cells (MSCs), which have shown promising results in promoting tissue regeneration and modulating inflammation. However, MSC therapy requires large numbers of cells, the generation of which is not feasible via conventional planar tissue culture methods. Scale-up manufacturing methods (e.g., propagation on microcarriers in stirred-tank bioreactors), however, are not specifically tailored for MSC expansion. These processes may, in principle, alter the cell secretome, a vital component underlying the immunosuppressive properties and clinical effectiveness of MSCs. This review outlines our current understanding of MSC properties and immunomodulatory function, expansion in commercial manufacturing systems, and gaps in our knowledge that need to be addressed for effective up-scaling commercialization of MSC therapy.

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Section: Human Originmentioning

confidence: 99%

Biological Considerations in Scaling Up Therapeutic Cell Manufacturing

et al. 2020

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“…20 However, human-derived reagents such as hPL and human serum need to be critically discussed as well. 21 Platelet concentrates for clinical use in humans have a shelf-life of between three and seven days at room temperature, 22 routinely resulting in their disposal when this shelf-life has expired. 23 To avoid potential competitive situations relating to the use of these valuable resources, we suggest that platelet concentrates should only be used for hPL production when they are past their expiry date for clinical use.…”

Section: Introductionmentioning

confidence: 99%

Case Studies Exemplifying the Transition to Animal Component-free Cell Culture

Weber¹,

Wiest²,

Oredsson

2022

Altern Lab Anim

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Cell culture techniques are strongly connected with modern scientific laboratories and production facilities. Thus, choosing the most suitable medium for the cells involved is vital, not only directly to optimise cell viability but also indirectly to maximise the reliability of the experiments performed with the cells. Fetal bovine or calf serum (FBS or FCS, respectively) is the most commonly used cell culture medium supplement, providing various nutritional factors and macromolecules essential for cell growth. Yet, the use of FBS encompasses a number of disadvantages. Scientifically, one of the most severe disadvantages is the lot-to-lot variability of animal sera that hampers reproducibility. Therefore, transitioning from the use of these ill-defined, component-variable, inconsistent, xenogenic, ethically questionable and even potentially infectious media supplements, is key to achieving better data reproducibility and thus better science. To demonstrate that the transition to animal component-free cell culture is possible and achievable, we highlight three different scenarios and provide some case studies of each, namely: i) the adaptation of single cell lines to animal component-free culture conditions by the replacement of FBS and trypsin; ii) the adaptation of multicellular models to FBS-free conditions; and (iii) the replacement of FBS with human platelet lysate (hPL) for the generation of primary stem/stromal cell cultures for clinical purposes. By highlighting these examples, we aim to foster and support the global movement towards more consistent science and provide evidence that it is indeed possible to step out of the currently smouldering scientific reproducibility crisis.

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“…High-throughput data generation for relevant big data that answers important safety questions, e.g., realistic exposures, potencies, mixtures, interindividual differences. Andersen et al, 2019;Jacobs et al, 2019;de Souza Santos et al, 2018;Aschner et al, 2017;Gordon et al, 2015;Patlewicz et al, 2014;Juberg et al, 2014;Smirnova et al, 2014;Hartung and Corsini, 2013;Parks Saldutti et al, 2013;Rossini and Hartung, 2012;Basketter et al, 2012;Kuegler et al, 2010;Hartung and Hoffmann, 2009;Leist et al, 2008a; Krewski et al, 2022;Maertens et al, 2022;Farhat et al, 2022;Caloni et al, 2022;Hoffmann et al, 2022a,b;Hartung, 2017cHartung, , 2021bHoffmann et al, 2017;Linkov et al, 2015;Hartung, 2009bMetabolomics Lippa et al, 2022Evans et al, 2020;Beger et al, 2019; ALTEX 35, 306-352. doi:10.14573/altex.1712081 Basketter, D. A., Clewell, H., Kimber, I. et al (2012). A roadmap for the development of alternative (non-animal) methods for systemic toxicity testing.…”

Section: Technology-enabled Toxicologymentioning

confidence: 99%

A call for a Human Exposome Project

Hartung

2023

ALTEX

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We prevent disease (unfortunately nobody knows how much).-Almost all products should undergo risk assessment.-Toxicology pioneered quality (GLP) and validation (incl. relevance). -Toxicology was the first preclinical science to adapt evidence-based approaches. However, we are not doing a good job selling this. We are the nay-sayers in product development who delay or stop all these fabulous product launches and this typically at a very late stage close to marketing. We are the harbingers of bad news about our food and our environment, the risks that spoil enjoying them. And the discipline of toxicology seems so close to pharmacology that academic chairs are increasingly being IntroductionThe theoretical case for a Human Exposome Project is easy to make. Wouldn't it be wonderful to understand the contribution of exposure to disease? The question is, however, how and is it feasible? But first, why call it a Human Exposome Project and not a Human Toxome Project 1 (Hartung and McBride, 2011)? This has to do with the undeserved mediocre reputation of toxicology, which has already led us to preferentially talk of safety science, risk science, regulatory science, next generation risk assessment, etc. Undeserved, because toxicology is actually big science: -Only a small percentage of disease is genetic, the rest is bad luck and exposure.

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Addressing potential ethical issues regarding the supply of human-derived products or reagents in in vitro OECD Test Guidelines

Cited by 6 publications

References 9 publications

Biological Considerations in Scaling Up Therapeutic Cell Manufacturing

Biological Considerations in Scaling Up Therapeutic Cell Manufacturing

Case Studies Exemplifying the Transition to Animal Component-free Cell Culture

A call for a Human Exposome Project

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