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Evaluation of the Quality of Biopreparations and Bioproduction

Major: Biotechnology and Bioengineering
Code of Subject: 8.162.00.M.25
Credits: 3
Department: Technology of Biologically Active Substances, Pharmacy and Biotechnology
Lecturer: Associate Professor, Ph. D. Zoriana Gubriі
Semester: 4 семестр
Mode of Study: денна
Learning outcomes:
- to know modern research methods in molecular biotechnology and bioengineering to creating new biotechnology objects;
- to know modern physicochemical and biophysical methods of identification of bio-organic preparations;
- to know modern methods of GMO identification, immunodiagnostics, and DNA-diagnostics;
- be able to apply the methods of analysis and mathematical modeling, to conduct microbiological, genetic and biotechnological experiments in scientific researches.
Required prior and related subjects:
Prerequisites:
Biomonitoring, biosafety, biosecurity and ecological expertise;
Control methods in biotechnology
Co-requisites:
Physicochemical and biophysical methods of identification of bio-organics;
Analytical and numerical methods
Summary of the subject:
Modern systems of quality assessment for finished bioproduсts by safety, microbiological, physicochemical and other indicators. Principals of Q8, Q9, and Q10: development, quality control, and risk management. The uncertainty concept for results analysis. The structure of detectors and rules of its operations. Methods of fluorescence detection of bioproduction. Validation of analytical methods. Detection of foods falsification. Modern analytical methods for the monitoring of xenobiotics in the feed, animal products, and food raw materials. Methods for evaluating the effectiveness of disinfectants, antiseptics, and preservatives. Determination of microorganism sensitivity to antibiotics. Modern problems of GMO control in food and food raw materials. Methods of microbiological, physicochemical control of the environment, industrial zone and food
Recommended Books:
1. Державна Фармакопея України - [1-е вид. Доповнення 3.] — Харків: Державне підприємство «Український науковий фармакопейний центр якості лікарських засобів», 2009. - 280 с.
2. Дубініна А.А. Методи визначення фальсифікації товарів: Підручник / Дубініна А.А., Овчиннікова І.Ф., Дубініна С.О. та ін. — К.: «Вид. дім «Професіонал», 2010. — 272 с.
3. Д.Х.Шах. Стандартные операционные процедуры в фармацевтическом производстве. Общие принципы/ Д.Х.Шах: Пер. С англ. Под ред.В.Т.Чумака, К.В.Крищука.- К.: Автограф, 2006.- 456 с.
4. Э. Тернер. Биосенсонры: основы и приложения: Пер. с англ. / Под ред. Э. Тернера, И.Карубе, Дж. Уилсона. – Москва: Мир, 1992.- 614
Assessment methods and criteria:
- written reports from practical work, oral questioning, control test – 30 points;
- final control (test) – 70 points (written-oral form).