ATLA 46, 2018

/ATLA 46, 2018

Editorial: Electronic cigarettes: Can dependable public health policies be developed and applied without relevant and reliable risk assessments?

Michael Balls and Robert Combes

The use of electronic cigarettes is being encouraged as a way of escaping from the harm resulting from conventional tobacco smoking, while scant attention is being paid to the long-term risks of inhaling electronic cigarette vapour. More information is needed for an acceptable risk assessment, from integrated non-animal testing and sound clinical investigations.
You need to register (for free) to download this article. Please log in/register here.

CAAT News and Views

CAAT staff

New Paper from CAAT’s Thomas Hartung Generates International Press Coverage

2nd Pan-American Conference for Alternative Methods in Brazil Sells Out

Meeting on Internationalisation of Read-across as a Validated New Approach Method for Regulatory Toxicology

Call for Proposals: 2019 Science-based Refinement Awards

You need to register (for free) to download this article. Please log in/register here.

2018-11-30T10:53:42+00:00 Tags: , |

IIVS News and Views

IIVS staff

IIVS Appointed to China’s Alternatives Working Group for Cosmetics

IIVS Collaborates with BASF and Givaudan to Validate a Non-animal Test for Regulatory Submissions

Quanshun Zhang to Deliver Keynote Lecture at CSLAS Annual Meeting

Inhalation Toxicology Webinar Series from PETA International Science Consortium (PISC)

IIVS Practical Methods Workshop 2019

IIVS at ESTIV 2018

IIVS Hosts Quarterly Meeting for Society of Quality Assurance’s Computer Validation and IT Compliance (CVIC) Specialty Section

You need to register (for free) to download this article. Please log in/register here.

2018-11-30T10:51:05+00:00 Tags: , |

A comparison of pyrogen detection tests in the quality control of meningococcal conjugate vaccines: The applicability of the Monocyte Activation Test

Vitor Fernandes Silva, Daniel da Silva Guedes Junior, Ivna Alana da Silveira, Alessandra Santos Almeida, Fernando de Paiva Conte, Isabella Fernandes Delgado, Cristiane Caldeira Silva, Octavio Augusto França Presgrave and Katherine Antunes de Mattos

The meningococcal C conjugate vaccine (MenCC) is an interesting model with which to test the efficacy of the Monocyte Activation Test (MAT) as an alternative method of pyrogen testing in the quality control of vaccines. The MenCC that has been produced by Bio-Manguinhos in Brazil is in the final development stage, and, as recommended in the guidelines for MenCC production, its pyrogen content must be determined by using the Limulus Amoebocyte Lysate (LAL) assay and the Rabbit Pyrogen Test (RPT). This represents an ideal opportunity to compare LAL and RPT data with data obtained by using a MAT system with cryopreserved whole blood and IL-6/IL-1beta as marker readouts. In order to assess the compatibility of the MAT with MenCC, endotoxin and non-endotoxin pyrogen content was quantified by using MenCC samples spiked with lipopolysaccharide (LPS), lipoteichoic acid or zymosan standards. The presence of the aluminium-based adjuvant interfered with the MAT, increasing the readout of IL-1beta in LPS-spiked MenCC batches. This infringed the product-specific validation criteria of the test, and led to IL-6 being chosen as the more suitable marker readout. No pyrogenic contaminants were identified in the MenCC batches tested, demonstrating consistency among the different systems (MAT, RPT and the LAL assay). In conclusion, the introduction of the MAT during MenCC development could contribute to the elimination of animal tests post-licensing, ensuring human protection based on an effective non-animal based method of quality control.

This article is currently only available in full to paid subscribers. Click here to subscribe, or you will need to log in/register to buy and download this article

Severity classification of surgical procedures and application of health monitoring strategies in animal research proposals: A retrospective review

Kathrin Herrmann and Paul Flecknell

Animal experimentation has been one of the most controversial areas of animal use, mainly due to the intentional harms inflicted upon the animals used. In an effort to reduce these harms, research on refinement has increased significantly over the past 20 years. However, the extent to which these efforts have helped to reduce the severity of the research procedures, and thus animal suffering, is uncertain. To provide an indication of the awareness and implementation of refinement methods, we reviewed the experimental techniques for 684 surgical interventions described in 506 animal research applications that had been sent to the German competent authorities for approval in 2010. In this paper, we describe and discuss the severity categorisation of the proposed surgeries and the planned health monitoring strategies. We found that the researchers frequently underestimated the levels of pain, suffering, distress and lasting harm that were to be inflicted on the animals. Furthermore, the planned health monitoring strategies were generally flawed. To ensure responsible treatment of animals and high-quality science, adequate training of research workers in recognising and alleviating animal suffering is essential.

This article is currently only available in full to paid subscribers. Click here to subscribe, or you will need to log in/register to buy and download this article

Does the stress of laboratory life and experimentation on animals adversely affect research data? A critical review

Jarrod Bailey

Recurrent acute and/or chronic stress can affect all vertebrate species, and can have serious consequences. It is increasingly and widely appreciated that laboratory animals experience significant and repeated stress, which is unavoidable and is caused by many aspects of laboratory life, such as captivity, transport, noise, handling, restraint and other procedures, as well as the experimental procedures applied to them. Such stress is difficult to mitigate, and lack of significant desensitisation/habituation can result in considerable psychological and physiological welfare problems, which are mediated by the activation of various neuroendocrine networks that have numerous and pervasive effects. Psychological damage can be reflected in stereotypical behaviours, including repetitive pacing and circling, and even self-harm. Physical consequences include adverse effects on immune function, inflammatory responses, metabolism, and disease susceptibility and progression. Further, some of these effects are epigenetic, and are therefore potentially transgenerational: the biology of animals whose parents/grandparents were wild-caught and/or have experienced chronic stress in laboratories could be altered, as compared to free-living individuals. It is argued that these effects must have consequences for the reliability of experimental data and their extrapolation to humans, and this may not be recognised sufficiently among those who use animals in experiments.

This article is currently only available in full to paid subscribers. Click here to subscribe, or you will need to log in/register to buy and download this article

2017 Lush Science Prize

Jenny McCann and Terry McCann

Now in its sixth year, the Lush Prize supports animal-free testing by awarding money prizes of up to £350,000 to the most effective projects and individuals who have been working towards the goal of replacing animals in product or ingredient safety testing. Prizes are awarded for developments in five strategic areas: Science; Lobbying; Training; Public Awareness; and Young Researchers. In the event of a major breakthrough leading to the replacement of animal tests in the area of 21st Century Toxicology, a Black Box Prize (equivalent to the entire annual fund) is awarded. The Science Prize is awarded to the researchers whose work the judging panel believe has made the most significant contribution to the replacement of animal testing in the preceding year. This Background Paper outlines the research projects that were shortlisted and presented to the judging panel as potential candidates for the 2017 Lush Science Prize. This process involved reviewing recent work of the relevant scientific institutions and projects in this area, such as the OECD, Human Toxome Project, UK NC3Rs, US Tox21 programme, ToxCast programme and the Human Toxicology Project Consortium. Recent developments in toxicity testing research were also identified by searching for relevant published papers in the literature, and analysing abstracts from conferences focusing on animal replacement in toxicity testing that had been held in the preceding 12 months — for example, the 2016 EUSAAT-Linz conference and the 2017 Society of Toxicology annual conference.
You need to register (for free) to download this article. Please log in/register here.

In vitro human tissues via multi-material 3-D bioprinting

David B. Kolesky, Kimberly A. Homan, Mark Skylar-Scott and Jennifer A. Lewis

This paper highlights the foundational research on multi-material 3-D bioprinting of human tissues, for which the Lewis Bioprinting team at Harvard University was awarded the 2017 Lush Science Prize. The team’s bioprinting platform enables the rapid fabrication of 3-D human tissues that contain all of the essential components found in their in vivo counterparts: cells, vasculature (or other tubular features) and extracellular matrix. The printed 3-D tissues are housed within a customised perfusion system and are subjected to controlled microphysiological environments over long durations (days to months). As exemplars, the team created a thick, stem cell-laden vascularised tissue that was controllably differentiated toward an osteogenic lineage in situ, and a 3-D kidney tissue that recapitulated the proximal tubule, a subunit of the nephron responsible for solute reabsorption. This highly versatile platform for manufacturing 3-D human tissue in vitro opens new avenues for replacing animal models used to develop next-generation therapies, test toxicity and study disease pathology.
You need to register (for free) to download this article. Please log in/register here.