Quality Control of Biological Products

Major: Biotechnology and Bioengineering
Code of subject: 6.162.02.E.095
Credits: 5.00
Department: Technology of Biologically Active Substances, Pharmacy and Biotechnology
Lecturer: Ph.D., lecturer Buchkevych I.R.
Semester: 5 семестр
Mode of study: денна
Learning outcomes: As a result of studying the discipline, the student must be able to demonstrate the following learning outcomes: know: - how the state quality control of biological products is carried out in Ukraine - to be acquainted with the activities of relevant laboratories for quality control of biological products. - features of quality control of medical immunobiological drugs (vaccines, antibiotics, enzymes of bacterial origin, microbial diagnostics, toxins, allergens sensitized by microbial antigens or antibodies). - have in-depth knowledge of the use of biologicals in food and agriculture. be able: - apply the acquired knowledge and understanding for the introduction of new technologies; - apply the acquired knowledge to analyze the quality of biological products. - Analyze the food additives available on the market - Analyze available on the market biological insecticides and acaricides, fertilizers, biological destructors of plant residues and be competent in their practical application.
Required prior and related subjects: General microbiology and virology Chemistry 3 (analytical chemistry, instrumental methods of analysis) Hygienic basics of food protection Modern application of biotechnological methods (industrial biotechnology) Raw material base of biotechnologies and waste bioutilization Bioengineering (cellular and genetic)
Summary of the subject: Quality control of biological products in Ukraine. Activities of the laboratory for quality control of biological products of the Institute of Microbiology and Virology. D.K. Zabolotny NAS of Ukraine. Activities of the National Center for Microorganism Strains (NCSM). Activities of the Department of Biotechnology and Quality Control of Viral Drugs of the State Scientific Control Institute of Biotechnology and Strains of Microorganisms. Stages of state quality control of MIBP. The procedure for quality control of MIBP in Ukraine. Production of vaccines, toxoids, protective antigens, serum. Production of antibiotics and enzymes of bacterial origin. Production of agglutination, precipitating, luminescent, microbial diagnosticums, toxins, allergens sensitized by microbial antigens or antibodies). Analysis of reforms in the quality control system of veterinary immunobiological agents (VIS). Connection with the development of the VIS quality control system abroad and the indirect influence of international organizations on the development of the biological industry in Ukraine. Food and feed additives that promote the early formation of normal intestinal microflora. Classification of biological drugs. Biological insecticides and acaricides. Biological inoculants. Biological destructors of plant residues. Biological fertilizers. Biologicals, which are in the list of pesticides and agrochemicals, are approved for use in Ukraine on vegetables.
Assessment methods and criteria: Execution and defense of laboratory works - 10 points; Intermediate test control - 20 points; Test test - 70 points.
Recommended books: 1. State Pharmacopoeia of Ukraine / State Enterprise "Scientific and Expert Pharmacopoeial Center". - 1st type. - H .: RIREG, 2001. - 556 p. 2. Quality, standardization and certification of medicines. Study guide / Sharapova T.A.,. Berest H.G., Bigdan O.A. - Zaporizhzhia 2016 3. Quality Control and Production of Biological Control Agents: Theory and Testing Procedures / J. C. van Lenteren.- CABI; First edition, 2003 4. Biological Control: Ecology and Applications / George E. Heimpel, Nicholas J. Mills, Cambridge University Press; 386 р, 2017