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Theme A WorkshopsWA1: Calf Serum Replacement in Cell Cultures WA1: Abstract Serum-Free Cell Culture Media Fetal bovine serum (FBS) is a common component of animal cell culture media. It is harvested from bovine fetuses taken from pregnant cows during slaughter. FBS is commonly harvested by means of a cardiac puncture without any form of anaesthesia. Fetuses are probably exposed to pain and/or discomfort, so the current practice of fetal blood harvesting is inhumane. There are many reasons that prevail upon the modern scientist to find ways to cope without using fetal bovine serum in cell cultures. For instance, ethical aspects of the production and marketing of the calf serum, difficulties in the official registration of products that are made with serum-dependent media, costs of down-stream processing, i.e. the purification of cell culture products, e.g. antibodies and recombinant proteins. In recent years, some progress has been made in serum-free cell culture, so various medium producers now offer serum-free culture media. However, their composition is usually not defined, i.e. some contain further undefined serum replacements, such as plant extracts. These formulations solve ethical conflicts, but they leave the problems of purification and registration unresolved. WA2: Replacement In Monoclonal Antibody Production Speakers: Vincent Dewar, GlaxoSmithKline Biologicals, Belgium; Coenraad Hendriksen, RIVM, The Netherlands; John McArdle, ARDF, USA; Simon Saxby, Xenova Research, UK; Frances Weis-Garcia, Memorial Sloan-Kettering Cancer Center, USA. Development of monoclonal antibodies (MAbs) revolutionized clinical treatment and biomedical research. The original possibility, however, of this technique replacing uses of laboratory animals often continues to be overlooked or ignored. In the decades following the original discovery, millions of animals died while available humane alternatives were under-utilized. Speakers in this workshop will provide comprehensive information on state-of-the-art current best practices for in vitro monoclonal antibody production in clinical, commercial, and research settings; a review of available small-scale in vitro MAb methods and resources; consideration of the pros and cons of using in vitro methods; and a case study detailing one large pharmaceutical company's switch to in vitro methods. WA3: Genomics, Proteomics, and Metabonomics WA3: Genomics, Proteomics, and Metabonomics Biological systems are a complex milieu of cell types, cellular functions, and/or cellular interactions that are often difficult to measure in detail. Many of the mechanisms for biological processes in such areas as toxicology, pharmacology, oncology, development, and aging biology still remain elusive. Genomic microarray technology has emerged as a powerful platform for biological process exploration and understanding. The technology allows the investigator to determine a gene expression profile for a biological process by measuring thousands of genes within a single experiment. Incorporation of genomic microarray technology provides a mechanism for such complex biological systems to be explored without the large-scale use of animals. In addition, this technology provides a useful system for establishing prediction models of biological responses using in vitro methodology that can be evaluated against currently existing in vivo animal and human data. WA4: Cryobiology/Low-Temperature Preservation of Cells and Tissues WA5: Statistical Reduction Strategies and Using In Vitro Data as Part of a Reduction Strategy WA5: Good Experimental Design and Statistics Can Save Animals, but How Can it be Promoted? A meta-analysis of 44 animal experiments on fluid resuscitation found that none of them were of a sufficient size to reliably detect a 50% reduction in mortality. The authors questioned whether these studies had made any contribution to human healthcare (Roberts et al 2002). Would a few well-designed large experiments use fewer animals than many small, badly designed, experiments? How can we recognize a "good" experiment? What role do funding organizations, ethical review procedures, regulators, and journal editors play in promoting good design and statistics? This workshop will discuss how the design and analysis of animal experiments can be improved. (Reference: Roberts, I., Kwan, I., Evans, P., Haig, S., 2002. British Medical Journal. 324:474-476.) WA5: Evaluation of Some In Vitro Tests to Reduce and Replace the Sub-Acute Animal Toxicity Studies The toxicologic and carcinogenic potential of chemicals is usually determined through a sequence of acute, 14-day, 90-day, and 2-year studies in rats and mice of both sexes. The National Toxicology Program does not conduct acute toxicity studies. Dose levels for 14-day toxicity studies are typically estimated from information in the literature. The toxicology information obtained from 14-day studies is used in selection of doses for 90-day studies. At present, in addition to refining the current testing protocols, NTP is evaluating some of the promising in vitro test methods to replace, partially or completely, the 14-day toxicity studies, especially for the chemicals where the dermal route of exposure is used. The in vitro assays being evaluated are, the Bovine Corneal Opacity and Permeability Assay (BCOP), the EpiDerm Bioassay, the Neutral Red Uptake (NRU) Bioassay, and the Primary Rat Hepatocyte Cytotoxicity Assay. Based on the results from six chemicals, the EpiDerm and NRU tests, in general, were more predictive of the responses observed in the animal studies.
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