ECVAM's Role in the Implementation of the Three Rs Concept in the Field of Biologicals

2002 ◽  
Vol 30 (2_suppl) ◽  
pp. 41-46 ◽  
Author(s):  
Coenraad Hendriksen ◽  
Klaus Cussler ◽  
Marlies Halder
Keyword(s):  
Quality Control ◽  
Animal Models ◽  
Validation Studies ◽  
Polyclonal Antibodies ◽  
Blood Products ◽  
Regulatory Authorities ◽  
Large Numbers ◽  
Related Quality ◽  
Living Organisms ◽  
The Three Rs

Biologicals can be defined as products that are derived from living organisms or are produced by them. They include vaccines, hormones, monoclonal and polyclonal antibodies, blood products and rDNA products. The production of conventionally produced biologicals requires an extensive batch-related quality control, to ensure that these products are both safe and potent. As several of the control tests rely on animal models, it is inevitable that large numbers of animals are used. Many initiatives have been undertaken in the last few decades to reduce, refine and replace the use of animals in this area. ECVAM has been involved in many activities to support the development, validation and implementation of these Three Rs methods. The role that ECVAM has played in a number of validation studies is summarised. It is concluded that ECVAM should continue to support the activities that have been shown to be successful, preferably in collaboration with the regulatory authorities.

Future Activities: ECVAM and the Quality Control of Biologicals

2002 ◽  
Vol 30 (2_suppl) ◽  
pp. 225-226
Author(s):  
Klaus Cussler ◽  
Marlies Halder ◽  
Coenraad Hendriksen
Keyword(s):  
Quality Control ◽  
Validation Studies ◽  
Information Exchange ◽  
Task Force ◽  
Large Numbers ◽  
Training Courses ◽  
The Three Rs ◽  
And Training

ECVAM's activities in the field of biologicals have contributed in many ways to the successful incorporation of Three Rs methods, as summarised elsewhere in these proceedings. The progress achieved is impressive, but large numbers of animals are still needed in order to meet the requirements stipulated by various regulations. ECVAM's activities in this area should therefore be continued and extended. Besides the well-established organisation of ECVAM workshops and contributions to conferences, further prevalidation and validation studies should be funded. In addition, studies on refinement, and training courses on validated and well-established Three Rs methods, could be initiated. There is a need for more communication and information exchange, especially between regulators and industry concerning the Three Rs. ECVAM could provide a suitable forum for such activities. An ECVAM Biologicals Task Force should be established in order to define a list of priorities.

ECVAM's Activities on Biologicals

2002 ◽  
Vol 30 (2_suppl) ◽  
pp. 125-128
Author(s):  
Marlies Halder ◽  
Michael Balls ◽  
Coenraad Hendriksen ◽  
Klaus Cussler
Keyword(s):  
Quality Control ◽  
Validation Studies ◽  
Financial Support ◽  
Test Methods ◽  
Priority Areas ◽  
The Three Rs ◽  
And Training ◽  
Financial Contributions

This paper summarises key activities initiated and the progress achieved between April 1993 and June 2002 in implementing the Three Rs in one of ECVAM's priority areas — the production and quality control of biologicals. These have included: organising nine key workshops; financially supporting and/or participating in a number of prevalidation and/or validation studies; financial contributions and sponsorship to relevant international workshops, symposia and conferences; and financial support for the compilation of manuals and expert reports, and training in test methods. The paper complements the papers of Hendriksen et al. and Cussler et al. included in these proceedings.

Animal Models and Alternatives in the Quality Control of Vaccines: Are In Vitro Methods or In Vivo Methods the Scientific Equivalent of the Emperor's New Clothes?

1995 ◽  
Vol 23 (1) ◽  
pp. 61-73
Author(s):  
Coenraad Hendriksen ◽  
Johan van der Gun
Keyword(s):  
Quality Control ◽  
Test Methods ◽  
In Vitro Test ◽  
Large Numbers ◽  
Alternative Approach ◽  
Inactivated Vaccines ◽  
Vitro Test

In the quality control of vaccine batches, the potency testing of inactivated vaccines is one of the areas requiring very large numbers of animals, which usually suffer significant distress as a result of the experimental procedures employed. This article deals with the potency testing of diphtheria and tetanus toxoids, two vaccines which are used extensively throughout the world. The relevance of the potency test prescribed by the European Pharmacopoeia monographs is questioned. The validity of the potency test as a model for the human response, the ability of the test to be standardised, and the relevance of the test in relation to the quality of the product are discussed. It is concluded that the potency test has only limited predictive value for the antitoxin responses to be expected in recipients of these toxoids. An alternative approach for estimating the potency of toxoid batches is discussed, in which a distinction is made between estimation of the immunogenic potency of the first few batches obtained from a seed lot and monitoring the consistency of the quality of subsequent batches. The use of animals is limited to the first few batches. Monitoring the consistency of the quality of subsequent batches is based on in vitro test methods. Factors which hamper the introduction and acceptance of the alternative approach are considered. Finally, proposals are made for replacement, reduction and/or refinement (the Three Rs) in the use of animals in the routine potency testing of toxoids.

scholarly journals COVID-19 vaccines: progress and understanding on quality control and evaluation

2021 ◽  
Vol 6 (1) ◽  
Author(s):  
Qunying Mao ◽  
Miao Xu ◽  
Qian He ◽  
Changgui Li ◽  
Shufang Meng ◽  
...  
Keyword(s):  
Quality Control ◽  
Global Health ◽  
Research And Development ◽  
Drug Evaluation ◽  
Control Laboratory ◽  
Vaccine Candidates ◽  
Regulatory Authorities ◽  
Quality Control Laboratory ◽  
Leading Role ◽  
National Quality

AbstractThe outbreak of COVID-19 has posed a huge threat to global health and economy. Countermeasures have revolutionized norms for working, socializing, learning, and travel. Importantly, vaccines have been considered as most effective tools to combat with COVID-19. As of the beginning of 2021, >200 COVID-19 vaccine candidates, covering nearly all existing technologies and platforms, are being research and development (R&D) by multiple manufacturers worldwide. This has posed a huge obstacle to the quality control and evaluation of those candidate vaccines, especially in China, where five vaccine platforms are deployed in parallel. To accelerate the R&D progress of COVID-19 vaccines, the guidances on R&D of COVID-19 vaccine have been issued by National Regulatory Authorities or organizations worldwide. The Center for Drug Evaluation and national quality control laboratory in China have played a leading role in launching the research on quality control and evaluation in collaboration with relevant laboratories involved in the vaccine R&D, which greatly supported the progression of vaccines R&D, and accelerated the approval for emergency use and conditional marketing of currently vaccine candidates. In this paper, the progress and experience gained in quality control and evaluation of COVID-19 vaccines developed in China are summarized, which might provide references for the R&D of current and next generation of COVID-19 vaccines worldwide.

scholarly journals Physiological importance of NGLY1, as revealed by rodent model analyses

2021 ◽  
Author(s):  
Haruhiko Fujihira ◽  
Makoto Asahina ◽  
Tadashi Suzuki
Keyword(s):  
Quality Control ◽  
Endoplasmic Reticulum ◽  
Control System ◽  
Animal Models ◽  
Rodent Model ◽  
Rodent Models ◽  
Future Perspectives ◽  
Physiological Functions ◽  
Physiological Importance ◽  
Glycan Degradation

Summary Cytosolic peptide:N-glycanase (NGLY1) is an enzyme that cleaves N-glycans from glycoproteins that has been retrotranslocated from the endoplasmic reticulum (ER) lumen into the cytosol. It is known that NGLY1 is involved in the degradation of cytosolic glycans (non-lysosomal glycan degradation) as well as ER-associated degradation (ERAD), a quality control system for newly synthesized glycoproteins. The discovery of NGLY1 deficiency, which is caused by mutations in the human NGLY1 gene and results in multisystemic symptoms, has attracted interest in the physiological functions of NGLY1 in mammals. Studies using various animal models led to the identification of possible factors that contribute to the pathogenesis of NGLY1 deficiency. In this review, we summarize phenotypic consequences that have been reported for various Ngly1-deficient rodent models, and discuss future perspectives to provide more insights into the physiological functions of NGLY1.

scholarly journals Enhanced Surveillance of Foodborne Mycotoxins by Immunochemical Assay

1988 ◽  
Vol 71 (6) ◽  
pp. 1075-1081 ◽  
Author(s):  
James J Pestka
Keyword(s):  
Quality Control ◽  
Solid Phase ◽  
Protein Conjugates ◽  
Sample Extract ◽  
Large Numbers ◽  
Wide Range ◽  
Enzyme Conjugate ◽  
Aflatoxin B ◽  
Sampling Procedures ◽  
Instrumental Methods

Abstract Mycotoxins are a chemically diverse group of fungal secondary metabolites with a wide range of toxic effects. Conventional thin-layer and instrumental methods of mycotoxin analysis are time-consuming and make routine safety and quality control screening of these compounds in agricultural commodities difficult. As an alternative, specific polyclonal and monoclonal antibodies have been raised against mycotoxin-protein conjugates and used in sensitive radioimmunoassays (RIAs) and enzyme-linked immunosorbent assays (ELISAs). One of the simplest ELISA approaches involves competition for a solid-phase antibody between a mycotoxin-enzyme conjugate and an unconjugated mycotoxin in the sample extract. ELISAs have been developed for aflatoxins B, and M„ zearalenone, T-2 toxin, and deoxynivalenol, which are highly specific, rapid (10 min), easily adaptable for analyzing large numbers of samples, and directly applicable to assaying methanol-water extracts of a wide range of foods. Several commercial mycotoxin ELISAs using this approach (most typically for aflatoxin B,) are currently being marketed. Since ELISAs will be used in large part by personnel with limited technical expertise, individual kits must be critically evaluated by analytical chemists for suggested sampling procedures, efficiency of extraction, crossreactivity, mycotoxin recovery, assay reproducibility, and product shelf-life prior to routine use in food safety and quality control screening

The Characteristics of Middle Aged Australian Women who Consult Acupuncturists

2007 ◽  
Vol 25 (1-2) ◽  
pp. 22-28 ◽  
Author(s):  
David Sibbritt ◽  
Jon Adams ◽  
Anne F Young
Keyword(s):  
Women’S Health ◽  
Women's Health ◽  
Service Use ◽  
Middle Aged ◽  
Large Numbers ◽  
Quality Of Life Scale ◽  
Life Scale ◽  
Significant Research ◽  
Related Quality ◽  
Health Related

Background Although an increase in the use of acupuncture in recent years has been identified, there are few studies that focus attention upon the characteristics of acupuncture users. This survey aimed at providing a first step towards addressing this significant research gap. Methods This study was conducted as part of the Australian Longitudinal Study on Women's Health, and examined the characteristics of acupuncture users among middle aged Australian women between 50 and 55 years old. Data were collected on demographic measures, health status and health service use. Results The paper reports on 11 202 middle aged women, surveyed in 2001. We estimate that 4.5% of middle aged women consult an acupuncturist. Women who consult an acupuncturist are less likely to be married or living in a de facto relationship, are more likely to have had a major personal illness in the previous year, to have suffered from a variety of symptoms or have significantly lower scores (ie poorer health) on all eight dimensions of the SF-36 health-related quality of life scale. Women who use acupuncture are also higher users of ‘conventional’ health services. Conclusion While the development of a research base and clinical applications for acupuncture are ongoing, health professionals should be aware that acupuncture is currently being used by large numbers of middle aged women. In addition, given the relatively higher prevalence of acupuncture use reported in our study, it is important that further research explores acupuncture use in more detail and the relationship between women's health issues and their use and experience of acupuncture.

The Evolution of the Three Rs

2009 ◽  
Vol 37 (3) ◽  
pp. 249-254 ◽  
Author(s):  
Sebastien Farnaud
Keyword(s):  
Animal Models ◽  
Experimental Technique ◽  
Charles Darwin ◽  
50Th Anniversary ◽  
Moral Values ◽  
150Th Anniversary ◽  
Technological Advances ◽  
New Ideas ◽  
The One ◽  
The Three Rs

Whilst the whole world is celebrating the bicentenary of the birth of Charles Darwin and the 150th anniversary of the publication of his renowned book, The Origin of Species, another anniversary should not be forgotten — the publication of The Principles of Humane Experimental Technique by W.M.S. Russell and R.L. Burch. The concomitance of the anniversaries of the two publications is not a coincidence, since, as reflected by the numerous quotes chosen by Russell from Darwin's masterpiece, numerous analogies can be found between the two works and the new ideas they describe. From a discrete birth, and after decades of struggle, the Three Rs concept can now celebrate its 50th anniversary, the result of its evolution through harsh selection and adaptation. The emergence of new types of techniques, in combination with the descent of modified old ones, testify to the undeniable change in our society toward a more efficient and more ethical science, through the progressive replacement of animal models. Both Darwin and Russell would no doubt have welcomed such progress, not only in terms of science, but also of moral values. One could also expect that, if Russell could have foreseen the incredible technological advances achieved 50 years later, where Replacement becomes a reality, as illustrated by some edifying examples, The Principles of Humane Experimental Technique would have probably been defined as the One R concept.

scholarly journals Quality Control for RNA-Seq (QuaCRS): An Integrated Quality Control Pipeline

2014 ◽  
Vol 13s3 ◽  
pp. CIN.S14022 ◽  
Author(s):  
Karl W. Kroll ◽  
Nima E. Mokaram ◽  
Alexander R. Pelletier ◽  
David E. Frankhouser ◽  
Maximillian S. Westphal ◽  
...  
Keyword(s):  
Quality Control ◽  
Ease Of Use ◽  
Rna Seq ◽  
Web Interface ◽  
For Profit ◽  
Not For Profit ◽  
Large Numbers ◽  
Sample Data ◽  
Meta Analyses ◽  
User Friendly

QuaCRS ( Quality Control for RNA- Seq) is an integrated, simplified quality control (QC) system for RNA-seq data that allows easy execution of several open-source QC tools, aggregation of their output, and the ability to quickly identify quality issues by performing meta-analyses on QC metrics across large numbers of samples in different studies. It comprises two main sections. First is the QC Pack wrapper, which executes three QC tools: FastQC, RNA-SeQC, and selected functions from RSeQC. Combining these three tools into one wrapper provides increased ease of use and provides a much more complete view of sample data quality than any individual tool. Second is the QC database, which displays the resulting metrics in a user-friendly web interface. It was designed to allow users with less computational experience to easily generate and view QC information for their data, to investigate individual samples and aggregate reports of sample groups, and to sort and search samples based on quality. The structure of the QuaCRS database is designed to enable expansion with additional tools and metrics in the future. The source code for not-for-profit use and a fully functional sample user interface with mock data are available at http://bioserv.mps.ohio-state.edu/QuaCRS/ .

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