Gamma Irradiation of Animal Serum: Maintaining the Cold Chain Throughout the Process

Brown, Sue; Croonenborghs, Bart; Head, Kevin; Senescu, Mara; Nims, Raymond W.; Plavsic, Mark; Versteegen, Rosemary

doi:10.12665/j17oa.brown

Cited by 4 publications

(2 citation statements)

References 4 publications

(14 reference statements)

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“…Follow up: Work to ensure that wherever possible blood donations that would otherwise be considered waste and disposed of, safety (Brown et al, 2018;Croonenborghs et al, 2016;Versteegen et al, 2016).…”

Section: (V) Competition With Altruistic Therapeutic Donationmentioning

confidence: 99%

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

Jacobs

Versteegen²,

Treasure

et al. 2019

ALTEX

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nance and growth of the cells used in many of the in vitro TGs. However, some cosmetics companies, including Lush 1 and the Body Shop 2 , have developed policies to avoid all animal generated products, and where in vitro methods are used, there is a preference to use xeno-free materials, sourced solely from humans, in the chemical testing procedures (Xeno-free conditions are defined as those not containing any elements that are not from the same species as the cells used, in this case, human (OECD, 2018a)). In line with a major global trend towards vegan products in the cosmetics industry, a wider interest in avoiding the use of animal-derived products in testing is therefore now emerging.Unnecessary suffering of fetuses in slaughterhouses is addressed at an international level, but consistent practical application and enforcement have been questioned. FBS has been

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Section: (V) Competition With Altruistic Therapeutic Donationmentioning

confidence: 99%

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

Jacobs

Versteegen²,

Treasure

et al. 2019

ALTEX

View full text Add to dashboard Cite

show abstract

“…[25] Process specifications should also clearly define all requirements, including those for maintaining the cold chain. [26] Figure 1 demonstrates the complexity of the serum irradiation process.…”

Section: Control Of the Irradiation Processmentioning

confidence: 99%

Gamma Irradiation of Animal Serum: General Regulatory Environment and Process Controls

Hanson¹,

Croonenborghs²,

Senescu³

et al. 2019

BioProcess J

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OECD workshop consensus report: Ethical considerations with respect to human derived products, specifically human serum, in OECD test guidelines

Jacobs¹,

Bult²,

Cavanagh³

et al. 2023

Front. Toxicol.

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The ethical needs and concerns with use and sourcing of human materials, particularly serum, in OECD in vitro test guidelines were explored in a dedicated international workshop held in 2019. The health-related aspects of the donation procedure, including tissue screening, donor health, laboratory work health protection, permission from the donor for commercial use, payment of the donors and the potential for exploitation of low-income populations and data protection of the donors; supply, availability, and competition with clinical needs; traceability of the serum and auditability/GLP needs for the Test Guideline Programme, were examined. Here we provide the recommendations of the workshop with respect to the use of human serum, and potentially other human reagents, specifically with regard to test method development for OECD Test Guideline utility as part of the Mutual Acceptance of Data requirement across all OECD member countries. These include informed donor consent terminology, a checklist of human serum information requirements to be included with the Good Laboratory Practise report, and suitable sources for human serum to ensure waste supplies are used, that can no longer be used for medical purposes, ensuring no competition of supply for essential medical use.

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Gamma Irradiation of Animal Serum: Maintaining the Cold Chain Throughout the Process

Cited by 4 publications

References 4 publications

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

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

Gamma Irradiation of Animal Serum: General Regulatory Environment and Process Controls

OECD workshop consensus report: Ethical considerations with respect to human derived products, specifically human serum, in OECD test guidelines

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