Pharmaceutical Biotechnology

Major: Biotechnology and Bioengineering
Code of subject: 6.162.01.E.060
Credits: 3.50
Department: Technology of Biologically Active Substances, Pharmacy and Biotechnology
Lecturer: Associate Professor, Ph.D. Zoriana Hubrii
Semester: 7 семестр
Mode of study: денна
Мета вивчення дисципліни: Pharmaceutical biotechnology is one of the most important modern scientific disciplines. Knowledge of its basics is necessary for a specialist who works both in laboratories and workshops of enterprises that produce medicinal products, and in scientific and control institutions. In each case, in addition to knowledge of the general foundations of this science, a deep familiarity with those sections that will be closest to the specialist's job profile is also mandatory. This is connected both with the penetration of biotechnological methods into the practice of diagnosis, prevention and treatment of various diseases, and with the fact that pharmaceutical biotechnology (its modern concepts) contributes to the formation of a person's worldview, adequate rapid development of scientific and technical progress in the modern world. Pharmaceutical biotechnology reflects the use of biologically active compounds (biocatalysts-cell-free enzyme complexes), unicellular and multicellular organisms in man-made technological processes that reproduce both natural processes and those not yet observed in nature. The purpose of studying pharmaceutical biotechnology is to acquaint students with the general principles and methods of using metabolic processes in cells to obtain various medicinal and biologically active substances, with the basics of technological processes and methods of their improvement, first of all, based on the use of the latest achievements in genetic engineering, molecular biology, chemistry and other fundamental sciences.
Завдання: The study of an educational discipline involves the formation of competencies in students of education: INT The ability to solve complex specialized tasks and practical problems characterized by complexity and uncertainty in biotechnology and bioengineering, or in the learning process that involves the application of theories and methods of biotechnology and bioengineering general competences: GC1. Ability to apply knowledge in practical situations GC5. Ability to learn and master modern knowledge professional competences: PC2. The ability to work with biological agents in biotechnological processes (cells of microorganisms, fungi, plants, animals; viruses; cell components; enzymes, immobilized cells and enzymes), to determine their morphology and physiological features. PCS1.7. Ability to apply knowledge of biotechnological processes of production of pharmaceuticals, diagnostic bioproducts and technological modes of biosynthesis, biotransformation, processing of biomass for its production.
Learning outcomes: PR14. Be able to justify the choice of a biological agent, the composition of the nutrient medium and the method of cultivation, the necessary auxiliary works and the main stages of the technological process, methods and methods of cultivation, biosynthesis, biotransformation, bioindication and biotesting of biological objects. PR29. Identify and perform validation work necessary to confirm the control of critical aspects of specific technological operations in biopharmaceutical production. AiB2. The ability to realize the need for lifelong learning in order to deepen the acquired and acquire new professional knowledge. AiB3. The ability to take responsibility for the work performed, to make decisions independently, to achieve the set goal in compliance with the requirements of professional ethics. KOM2. The ability to use various methods, including modern information technologies, for effective communication at the professional and social levels.
Required prior and related subjects: Previous academic disciplines: Biology; General microbiology and virology; General biotechnology; Pharmaceutical chemistry. Associated and following academic disciplines: Bioengineering (cellular, genetic); Biotechnology of fermentation.
Summary of the subject: Features and main achievements of modern pharmaceutical biotechnology. The main bioobjects used for the production of medicinal, prophylactic and diagnostic drugs. Components of the biotechnological process. Rules of Good Manufacturing Practice for Biotechnology. Biotechnology of antibiotics. The problem of finding, creating and using antibiotics in medical practice. Biotechnology of amino acids. Medicines based on free and immobilized enzymes, their combinations with other medicines. Preparations based on live cultures of symbiont microorganisms. Genomics and proteomics. Their importance for the creation of new medicines.
Опис: Modern biotechnology in the creation and production of medicinal products. Components of the biotechnological process. The structure of biotechnological production. Biotechnological aspects of pharmaceutical production from the point of view of ecology. GMP, GLP, GCP rules. Rules of Good Manufacturing Practice for Biotechnology. Biotechnology of antibiotics. Biotechnology of amino acids. Application of amino acids in medicine. Biosynthesis of L-amino acids by cells of microorganisms. Microbiological production of amino acids. Biotechnology of enzymes. Application of enzymes in medical practice. Enzymopathology. Enzyme diagnosis. Enzyme therapy. Microbiological synthesis of enzymes for medical purposes. Biotechnological preparation of probiotics. Biotechnology of vaccine preparations. Biotechnology of obtaining heparins Biotechnology of phospholipids. Phospholipids in biological membranes. Biotechnological production of phospholipids. Biotechnology of pharmaceutical preparations from yeast. Genomics and proteomics, their significance for the creation of new medicines.
Assessment methods and criteria: The following types of control are used: current and semester. Current control is a control that is carried out during the study of an educational discipline in order to identify the degree of understanding of the student's learned educational material and the ability to apply it in practical work. Current control is carried out in laboratory classes. The obtained results of current control are used by the teacher to adjust the methods and means of teaching students, organize their independent work, and during the semester control and assessment of students' knowledge. Forms of ongoing control: individual survey upon admission to laboratory work, evaluation of laboratory work, protection of laboratory work. Semester control is a type of final control that reveals the student's level of mastery of the academic discipline, taking into account the results of the current control. Examination form: written (test) with a mandatory oral component.
Критерії оцінювання результатів навчання: Current control - 30 points: Laboratory works - 20 points; Homework - 10 points. Examination control - 70 points: written component - 60 points; oral component - 10 points.
Порядок та критерії виставляння балів та оцінок: 100–88 points – (“excellent”) is awarded for a high level of knowledge (some inaccuracies are allowed) of the educational material of the component contained in the main and additional recommended literary sources, the ability to analyze the phenomena being studied in their interrelationship and development, clearly, succinctly, logically, consistently answer the questions, the ability to apply theoretical provisions when solving practical problems; 87–71 points – (“good”) is awarded for a generally correct understanding of the educational material of the component, including calculations, reasoned answers to the questions posed, which, however, contain certain (insignificant) shortcomings, for the ability to apply theoretical provisions when solving practical tasks; 70 – 50 points – (“satisfactory”) awarded for weak knowledge of the component’s educational material, inaccurate or poorly reasoned answers, with a violation of the sequence of presentation, for weak application of theoretical provisions when solving practical problems; 49-26 points - ("not certified" with the possibility of retaking the semester control) is awarded for ignorance of a significant part of the educational material of the component, significant errors in answering questions, inability to apply theoretical provisions when solving practical problems; 25-00 points - ("unsatisfactory" with mandatory re-study) is awarded for ignorance of a significant part of the educational material of the component, significant errors in answering questions, inability to navigate when solving practical problems, ignorance of the main fundamental provisions.
Recommended books: 1. Фармацевтична біотехнологія: Біотехнології виробництва готових лікарських форм: навч. посібн. / Ю. М. Краснопольський, Д. М. Пилипенко. – Харків: ТОВ «Друкарня мадрид», 2020. – 279 с. 2. Фармацевтическая биотехнология: Аспекты фармацевтической химии: учеб. пособие / Ю.М.Краснопольский, О. В. Звягинцева. – Харьков : НТУ «ХПИ», 2018. – 248 с. 3. Актуальные проблемы биотехнологии и биоинженерии / под ред. А. Н. Огурцова. – Харьков : «Типография Мадрид», 2019. – 240 с. 4. Фармацевтичні та медико-біологічні аспекти ліків. Навчальний посібник / За ред. І.М.Перцева . - Видання друге. – Вінниця: НОВА КНИГА, 2007. – 728 с. 5. Буценко Л.М., Пенчук Ю.М., Пирог Т.П. Технології мікробного синтезу лікарських засобів. - К.: НУХТ, 2010. — 323 с.
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Академічна доброчесність: The policy regarding the academic integrity of the participants of the educational process is formed on the basis of compliance with the principles of academic integrity, taking into account the norms "Regulations on academic integrity at the Lviv Polytechnic National University" (approved by the academic council of the university on June 20, 2017, protocol No. 35).