Home/ Majors directory/Biotechnology and Bioengineering/Quality Control of Biological Products
Quality Control of Biological Products
Major: Biotechnology and Bioengineering
Code of subject: 6.162.02.E.064
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
Завдання: РН1: ЗН13 Basic knowledge and ability to use the integration of information resources and effective navigation in them.
РН2: УМ13 To carry out the selection of necessary biological preparations in agro-industry
РН3: УМ16: To be able to summarize and systematize information for carrying out bacteriological research in the conditions of a modern quality control laboratory
РН4: АиВ1: Ability to adapt to new situations and make appropriate decisions.
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: The discipline "Quality control of biological preparations" forms in students modern ideas about the rapid development of the production of biological preparations in Ukraine and the world, in accordance with the constant strengthening of quality control in this industry. Currently, state control and supervision of the safety and quality of biological preparations, their testing for the purpose of registration is entrusted to the State Scientific Control Institute of Biotechnology and Strains of Microorganisms. The availability of standard biological material is a mandatory condition for life support of virological, bacteriological research, molecular genetic research, research in the direction of cellular biotechnology and genetic engineering. The development of an actively functioning storage system for industrially promising samples of biological material ensures not only the uninterrupted operation of enterprises producing relevant products, but also serves as a basis for further improvement and development of biotechnologies, in particular, the production of veterinary immunobiological drugs.
The work is aimed at conducting research on checking the quality of biological materials of viral origin and nutrient media for them, with the aim of preventing the introduction of low-quality drugs used for the prevention and diagnosis of infectious diseases of farm animals and poultry into the practice of veterinary medicine in Ukraine.
In recent years, we have witnessed the rapid development of technologies, in which an alternative to the chemical method is the biological protection of plants from pests, diseases and weeds, which is becoming more and more relevant with each passing year. Practical interest in the biological method is due to the fact that it is safe for humans and warm-blooded animals. Biological protection agents do not pollute the environment, exhibit high selectivity, are convenient for mass production, and have inexhaustible resources for this. That is why in ecologically developed countries, biological protection of plants is an environmentally safe and priority form in long-term programs of combating harmful organisms.
In the current conditions, every year, producers give more preference to biological protection of agricultural crops.
As a result of studying this discipline, the student acquires an understanding of how state supervision over the production and use of biological preparations takes place, the skills to work and process bacteriological research data in the conditions of a modern laboratory, acquires the appropriate skills and competences necessary for mastering knowledge from further professional disciplines, which will allow them to be successfully used in future professional activities in the field of biotechnology and bioengineering.
Опис: Topic 1. Introduction. Quality control of biological preparations in Ukraine.
Quality control of biological preparations in Ukraine. Activities of the laboratory for quality control of biological preparations of the Institute of Microbiology and Virology named after D.K. Zabolotny National Academy of Sciences of Ukraine.
Activities of the National Center for Strains of Microorganisms (NCSM). Activities of the Department of Biotechnology and Quality Control of Viral Preparations of the State Scientific Control Institute of Biotechnology and Strains of Microorganisms.
Topic 2. Peculiarities of quality control of medical immunobiological preparations.
Stages of state quality control of MIBP. The procedure for conducting quality control of MIBP in Ukraine.
Topic 3. Production and quality control of prophylactic biological preparations.
Production of vaccines, toxoids, protective antigens, serum.
Topic 4. Production and quality control of medical biological preparations.
Production of antibiotics and enzymes of bacterial origin.
Topic 5. Production and quality control of diagnostic biological preparations.
Production of agglutinating, precipitating, luminescent, microbial diagnostics, toxins, allergens, sensitized by microbial antigens or antibodies).
Topic 6. Formation of the quality control system of veterinary immunobiological means in Ukraine.
Analysis of reforms in the system of quality control of veterinary immunobiological products (VIZ). Connection with the development of the HIV quality control system abroad and the indirect influence of international organizations on the development of the biological industry in Ukraine.
Topic 7. Use of food additives and biopreservatives.
Food and feed additives that contribute to the early formation of normal intestinal microflora. The necessity and importance of using biopreservatives.
Topic 8. Biological preparations - alternative protection of agricultural crops from diseases and pests
Classification of biological drugs. Biological insecticides and acaricides. Biological inoculants. Biological destroyers of plant residues. Biological fertilizers. Biopreparations included in the list of pesticides and agrochemicals are allowed to be used on vegetables in Ukraine.
Assessment methods and criteria: The main methods of knowledge diagnosis are: current (PC) and semester control (SC), which is carried out from the educational material, the scope of which is determined by the work program of the discipline for the semester.
Current control is carried out during lectures and laboratory classes in order to check the level of assimilation of theoretical knowledge and skills of the student. PC is carried out in the form of an individual scientific task, in the form of: written and oral express control (tasks include tests: Level I - 1 point, Level II - 2 points, Level III - 3-4 points) and evaluation of the student's work in laboratory classes (each laboratory work is valued at 10 points, of which 2 points are for assessing the student's knowledge of preparation for laboratory work (admission), 2 points are for performance evaluation and 6 points for defending the laboratory work. At the end of the semester, the average score is displayed).
Критерії оцінювання результатів навчання: Performance and defense of laboratory work - 10 points;
Individual scientific task - 20 points;
Control assessment work - 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