Background: In recent years, due to the outbreak of new infectious diseases, re-emerging diseases and bio-terrorist threats, the biological safety for laboratories is essential\r\n', u'Objectives: to evaluate knowledge and practices related to biosafety of researchers in microbiological laboratories\r\n', u'Subjects and method: The study was carried out in the period 2006-2007. Questionnaires and checklists were used for the direct interview the knowledge and observe the practices related to biological safety of 97 laboratory technicians from microbiology laboratories of 22 provincial centers for preventive medicine, which represent for all areas in Vietnam.\r\n', u'Results: The percentage of technicians defines correctly the hazardous groups of some common pathogens are 8.2-33%. The percentage of technicians define correctly the transmission routes of Bacillus anthracis, Staphylococus, Streptococcus are 1%, 15% and 19.6%, respectively. The opinion that thay can wear the laboratory blouse out of laboratories, bring personal belongings into the laboratory and pipeting by mouth are 21.6%, 50.5% and 23.7%, respectively. Regarding laboratory practices: The percentage of technicians does not use gloves is 37.8%; pipeting by mouth: 22.6%. Over 40% technicians do not disinfect working area or washing hands with alcohol after experiments\r\n', u'Conclusion: The results of this study are a basis for planning programs to train, supervise and improve the operational quality of the microbiological laboratory of the provincial preventive health care centers.\r\n', u'\r\n', u'\r\n', u'
Health Knowledge ; Attitudes ; Practice ; Biotechnology/ standards ; Safety/ standards ;

With the research and development of genetically engineered animals (GEAs) in breeding of new variety, xenotransplantation, bioreactor and disease model, biosafety issues of GEAs have attracted widespread attentions worldwide. So far, governments and agencies have established corresponding laws and regulations to regulate research and application of GEAs or their derived products. We reviewed research contents, evaluated principles, policies and procedures for biosafety of GEAs, also enumerated upcoming approved products of GEAs. Finally, we suggested perspectives of research and application of GEAs or their derived products.
Agriculture ; economics ; legislation & jurisprudence ; Animals ; Animals, Genetically Modified ; genetics ; growth & development ; Biotechnology ; economics ; legislation & jurisprudence ; Food Safety ; Food, Genetically Modified ; economics ; standards ; Laboratories ; standards

AIMTo establish methods and requirements for quality control of recombinant human tumor necrosis factor receptor Fc fusion protein (rhTNFR-Fc).

METHODSBiological potency of rhTNFR-Fc was determined by neutralizing the bioactivity of TNF-alpha. rhTNFR-Fc samples were reduced by beta-mercaptoethanol and the peptide map was performed by tryptic digestion. Residual protein A and the host cell protein content were detected by ELISA. Anti-TNFR and anti-Fc antibodies were used in ELISA for detection of the rhTNFR-Fc content.

RESULTSThe quality control methods, such as bioassay, peptide map, residual protein A detection, were established and used for quality control of rhTNFR-Fc. The unit of rhTNFR-Fc (AU) was defined according to the international unit of TNF-alpha. The specific activity was up to 8 x 10(4) AU.mg-1. The requirements for quality control of rhTNFR-Fc were established.

CONCLUSIONThe methods and requirement were used for quality control of rhTNFR-Fc products.

Animals ; Biotechnology ; methods ; Cell Division ; drug effects ; Etanercept ; Immunoglobulin G ; biosynthesis ; chemistry ; pharmacology ; Mice ; Peptide Mapping ; Quality Control ; Receptors, Tumor Necrosis Factor ; biosynthesis ; chemistry ; Recombinant Fusion Proteins ; biosynthesis ; chemistry ; pharmacology ; Technology, Pharmaceutical ; standards ; Tumor Cells, Cultured

AIMTo establish methods and requirements for the quality control of recombinant human neu epitope peptide 12.

METHODSBiological activity of recombinant human neu epitope peptide 12 was evaluated in FVB/N transgenic mice (TgN MMTV neu 202 Mul, Jackson Lab., USA) administered with samples. The percentage of antibody-positive mice detected by ELISA was used in the biological activity evaluation. The peptide map was performed by peptic digestion. The antigen content was determined by SEC-HPLC.

RESULTS AND CONCLUSIONThe quality control methods, such as biological activity, peptide map, antigen content, and the requirements for the quality control of recombinant human neu epitope peptide 12 were established. The established methods and requirements were already used for the quality control of recombinant human neu epitope peptide 12 products.

Animals ; Antibodies, Monoclonal ; analysis ; Biotechnology ; methods ; Epitopes ; analysis ; chemistry ; immunology ; Female ; Genes, erbB-2 ; Humans ; Mice ; Mice, Inbred BALB C ; Mice, Transgenic ; Peptide Fragments ; chemistry ; immunology ; Peptide Mapping ; Quality Control ; Receptor, ErbB-2 ; analysis ; chemistry ; immunology ; Recombinant Fusion Proteins ; analysis ; chemistry ; immunology ; Technology, Pharmaceutical ; standards