The Foundation Of The Technology Platform Of Public Service Concerning The Evaluation Of Health-related Products And Animal Experiments

To establish the technology platform of public service that serves to innovative biotechnology and biomedicine industry, this thesis designs "the technology platform of public service concerning the evaluation of health-related products and animal experiments" according to the overall plan of National Base of Bioindustry in Wuhan. We have also put the programme into execution in Jiufeng Innovative Park, while the core of the programme is to set up the technical conditions that comply with the international "Good Laboratory Practice (GLP)". For this reason, how to control the influencing factors of the systematic residuals, accidental errors and gross errors of animal experiments is considered. We utilize the building structure and craft, air purification technology, independent ventilatory technology in animal feeding, information and control technology, and the biological characteristics of experimental animals, with a purpose to establish barrier animal-experiment facilities of constant temperature, constant humidity, clean and odourless, and positive pressure. The cozy barrier-environment of technical peronnel is physically segregated from the living barrier-environment of animals to meet the well-beings of personnel and animals. We also utilize the renewable-energy technology to set up distributing energy station, with the view to meet the needs of energy cost required by IVC animal barrier-system and sanitary hot water required by personnel, and can also achieve the purpose of energy-saving and economical operation. Based on the requirment of toxicology experiments concerning medicines, farm chemicals, health-care food, and cosmetics, we establish relevant toxicity laboratory, pathology laboratory, clinical examination laboratory, cell culture laboratory, Ames laboratory, functional laboratory, central control room, archives, and sample room etc.. Moreover, according to the international advanced GLP operation management, we aim to build an administrative organization with evaluating technique of integrate system, a professional technical team, a variety of managerial system, and standard operation procedure, making sure every toxicity experimental results can be objective, real, quality-controllable, and retrospective. The results show that, this technology platform consists of a Comprehensive Building with area of4235.8square meters and a Animal Experiment Building with area of7894.2square meters, with total investment of121million RMBs. All the platforms are as follows:①Dthe evaluating technology platform of drug safety GLP research and drug’s safety routine test;②he platform of pharmacodynamic screening as well as evaluation and pharmacokinetics research;③the technology platform of agriculture chemical registration in toxicity experiments and evaluation;④the evaluating and examing platform concerning the toxicity and function of foods including health-care foods;⑤he evaluating and examing platform of cosmetics inspection;⑥he test platform of physio-chemical and microorganism analysis concerning biological products⑦he open technology platform of public test evaluation and life science experiments. The platform resources include3,200IVC mice cages,4,595IVC rat cages,1,567rabbit cages,740cobaya cages,180dog cages,56monkey/pig cages,6cat cages, and81pyrogen cages. The ecnomic performance can be achieved everyday with64,863.5RMBs. Its trial running results indicated that the technology platform of public service has been recognized by the following agencies:National Development and Reform Committee, National Ministry of Agriculture, Food and Drug Administration, National Laboratory Accreditation, Hubei Provincial Department of Public Health, Hubei Provincial Department of Technology, Wuhan National Base of Bioindustry, Hubei Academy of Preventive Medicine, and Hubei Center for Disease Control and Prevention. The relevant accreditation and certification have been achieved. The operation and implementation of the technogy platform for public service are beneficial to the innovation research and industrialization of biological medicine and biotechnology.