Quality INSIGHTS


Reference DNA from Key Mouse Strains Now Available

Reproducibility Requires Genetic Quality The genetic integrity of laboratory mice and rats is an important contributor to research reproducibility, which is why commercial animal vendors invest in maintaining the genetic quality of standard inbred and outbred strains. As the technology to produce genetically engineered models (GEMs) becomes more widespread, a growing majority of GEMs are bred and used at individual institutions. This decentralization has created concerns regarding...

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rasH2 and the 3Rs

In the spirit of Russell and Burch's 3Rs, scientists are developing new tools and methodologies to reduce the use of animal models wherever possible. A very good example is the rasH2 mouse model, which was developed as an alternative to the traditional, two-year carcinogenicity testing of compounds for mutagenic and non-mutagenic chemically- induced tumor formation. Transgenic Mice as an Ethical Alternative The rasH2 mouse was developed in...

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Improving Quality with the 3Rs

Designing your animal model studies with the 3Rs in mind — Replace, Reduce, Refine — is not only more humane, but can measurably improve the quality and efficiency of your research projects. When we think of improving quality in the life sciences, we might immediately jump to poorly calibrated equipment, expired reagents, or utilizing unvalidated processes. It is obvious that these will have a negative effect on...

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Humanized Mice at the Summer Toxicology Forum

The 43rd annual Summer Toxicology forum meeting was held on July 10-12, 2017 in Annapolis Maryland. The afternoon of July 10th was dedicated to a section titled "Use of Humanized Mice for Drug Development". The session was moderated by James Monroe, PhD, senior principle scientist at Merck Research Laboratories, and included presentations by researchers at the FDA, Merck, Yale, and Taconic Biosciences followed by a panel discussion...

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Webinar Recap: Historical Control Database of Spontaneous Lesions in Tg.rasH2 Mice

On May 25, 2017, Dr. Madhav Paranjpe presented a webinar on the state of evidence surrounding the use of Tg.RasH2 carcinogenicity studies as a substitute for the two-year mouse bioassay. His presentation — "Historical Control Database of Spontaneous Lesions (Neoplastic & Non-Neoplastic) in Transgenic Tg.rasH2 Mice" — covered evidence drawn from fifty peer-reviewed studies, personal experience, and analysis of the growing body of historical control data supporting...

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Proposed Changes to ICH Carcinogenicity Testing Guidelines — Decision Delayed

While evidence mounts in support of revised carcinogenicity testing guidelines, the number of Carcinogenicity Assessment Documents (CAD) submitted to the ICH S-1 expert working group fell below expected levels. After extending the submission period by two years9, the expert working group (EWG) will meet in June of 2017 to review the conclusions of drug regulatory agencies on the viability of excluding some pharmaceutical agents from the requirement...

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Mutation Reduces Immune Response in C57BL/6J Mice

Researchers from the University of Iowa inadvertently identified an Nlrp12 missense mutation which inhibits immune responses in C57BL/6J mice. Further investigation reveals the mutation occurred prior to 1971, potentially impacting decades of research conducted on affected mouse models. Reduced Neutrophil Recruitment in C57BL/6J In this study, the authors compared C57BL/6J and C57BL/6NTac mice and noted that C57BL/6J mice had reduced neutrophil recruitment. Initially hypothesizing the difference was...

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Rat Polyomavirus 2 - A New Agent of Concern?

Recently, a novel rodent polyomavirus, rat polyomavirus 2 (RPyV2), was discovered. This new agent was isolated from a colony of highly immunodeficient rats which developed clinical illness, including emaciation, labored breathing and mortality, particularly among breeding females and pups. IDEXX BioResearch, working collaboratively with the affected academic institution, was finally able to identify the cause as a novel rat virus, which they named Rattus norvegicus polyomavirus 2...

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Variations within Outbred Strains: Know Your Strains and Stocks

The Sprague Dawley® (SD) rat is one of the most popular outbred stocks, with application across many therapeutic areas as well as ADMET studies. The SD is an outbred stock, meaning that there is genetic variation within the stock, and each individual varies in genetic makeup. Genetic variation is maintained through well-defined rotational mating schemes, which are designed to maintain heterozygosity within the population over time. The...

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Animal Model Quality: Transportation and Environmental Factors

What are the most important factors in assessing the quality of an animal model? In Part I, Quality Considerations In The Use of Animal Models, we discussed two of the four quality considerations for using laboratory mice: health and genetics. To recap: It's important to understand the different health standards when assessing an animal model. Commercial providers often make them available online, or they can be requested...

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