Pharmaceutical Biotechnology

Major: Biotechnology and Bioengineering
Code of subject: 6.162.01.E.088
Credits: 3.50
Department: Technology of Biologically Active Substances, Pharmacy and Biotechnology
Lecturer: Associate Professor, Ph.D. Zoriana Gubrii
Semester: 7 семестр
Mode of study: денна
Learning outcomes: •to apply their knowledge and understanding to producing and operation of biotechnological manufacture; •to know the methods of monitoring biological objects, quality of raw materials and biotechnological products and to conduct qualitative and quantitative analysis of inorganic, organic and biological substances; •to validate of control critical points of manufacturing operations for biopharmaceutical production; •to determine and optimize the technological parameters for the biotechnological process.
Required prior and related subjects: Prerequisites: Biology, General Microbiology and Virology, General Biotechnology Co-requisites: Bioengineering (cell and genetic), Pharmaceutical Chemistry.
Summary of the subject: Modern biotechnology in medicines manufacture. The structure of biotechnological pharmaceutical industries and environmental problems. GMP system to manufacture and quality control of medicines. GLP, GCP. Biotechnology of antibiotics. Biotechnology of amino acids. Pharmaceutical enzymology. Preparations based on living cultures of symbiont microorganisms. Immunobiotechnology - antiserum and vaccines. The classification of vaccines. Genomics and proteomics and their importance for the development of new drugs.
Assessment methods and criteria: • written reports from laboratory work, oral questioning, final test – 30 points • final control (test) –70 points (written-oral form)
Recommended books: 1.Л.М.Буценко. Технології мікробного синтезу лікарських засобів / Л.М.Буценко, Ю.М. Пенчук, Т.П.Пирог. - К.:НУХТ, 2010. – 323с. 2.Т.П.Прищеп. Основы фармацевтической биотехнологии / Т.П.Прищеп, В.С.Чучалин, К.Л. Зайков, Л.К.Михалева, Л.С.Белова. – Р/нД.:Феникс;Томск:Изд.НТЛ, 2006. – 256 с. 3.В.А.Галынкина. Фармацевтическая микробиология /В.А.Галынкин, В.И.Кочеровец. -М.:Арнебия, 2003.- 351с. 4.Егоров Н.С. Основы учения об антибиотиках / Егоров Н.С. - М.:Наука, 2004.- 525 с.