Simulation and Scaling of Biotechnological Production in the GMP System (курсовий проєкт)

Major: Biotechnology and Bioengineering
Code of subject: 7.162.03.O.011
Credits: 3.00
Department: Technology of Biologically Active Substances, Pharmacy and Biotechnology
Lecturer: Assistant, Ph.D., Natalija Monka
Semester: 2 семестр
Mode of study: денна
Learning outcomes: PRE08. Plan and manage research projects, scientific and technical, and/or production projects in the field of biotechnology, based on current trends in science, technology, and society. PRE10. Introduce the most effective biotechnological methods and techniques in practical production activities based on the evaluation of the effectiveness of advanced biotechnologies and taking into account the general trends in the development of new biotechnologies in leading countries. PR11. Fluently communicate orally and in writing in state and foreign languages. Discuss the results of research, discuss the innovation and production management and biotechnology with experts and non-specialists. PRE12. Analyze and take into account in practice the trends of scientific and technological development of society and the biotechnology industry. PRE17. Evaluate, analyze and select solutions for the management of complex biotechnological processes, taking into account goals, constraints, forecasts, and risks.
Required prior and related subjects: Prerequisites: Оrganization of biotechnical production (design and equipment); Mathematical modelling of microbiological processes; Regulatory support of biotechnology industry; Processes and equipment of biotechnology industry; Co-requisites: Modern application of biotechnological methods (industrial biotechnology); Modern application of biotechnological methods (biotechnology of food industries); Fulfilment of Master's qualification work
Summary of the subject: Execution of course project, preparation of explanatory note and graphical part. Preparation for the presentation and defense of the course project. Course project should be done in accordance with the requirements and principles of good manufacturing practice (GMP) and designed as a project document based on laboratory methods that involves the development or simulation of new technology and manufacture. Experimental-calculation research work which based on experimental research in the scientific group that includes: a review of literature data, processing of experimental data, experimental methods and results of mathematical calculations using computer programs, proposed technology.
Assessment methods and criteria: • content and correctness of calculations and drawings - 50 points, the use of modern references – 5 points, precision of execution - 5 points. • final control (defense of course project, test) – 40 points (oral form).
Recommended books: 1. Sydorov YU.I., Vlyazlo R.Y., Novikov V.P. Protsesy i aparaty mikrobiolohichnoyi ta farmatsevtychnoyi promyslovosti. — L?viv: Intelekt-Zakhid, 2008. — 736 s.. 2. Protsessу y apparatу byotekhnolohyy: fermentatsyonnуe apparatу : ucheb. posobye dlia akademycheskoho bakalavrata / A. Yu. Vynarov [y dr.] ; pod red. V. A. Bуkova. — 2-e yzd., pererab. y dop. — M. : Yzdatel- stvo Yurait, 2018. — 275 s. 3. Proektyrovanye chystуkh pomeshchenyi. Pod red. V. Uaita. Per. s anhl. - M.: yzd. "Klynrum", 2004. - 360 s. 4. Collard J.-M., Breyer D., Renckens S., Sneyers M. Вiotechnology – Vol. 1 - Biosafety in Biotechnology – 2019. - 22 р. 5. Osnovy biobezpeky (ekolohichnyi skladnyk) : navch. posib. / L. P. Novoselska, T. H. Ivashchenko, V. P. Handziura, O. P. Kulinych ; za zah. nauk. red. d.b.n. O. I. Bondaria. – K. : Instytut ekolohichnoho upravlinnia ta zbalansovanoho pryrodokorystuvannia, 2017. – 180 s. 6.Nastanova Ministerstva okhorony zdorov?ya Ukrayiny. Standartyzatsiya ministerstva okhorony zdorov?ya Ukrayiny. Likars?ki zasoby. Nalezhna vyrobnycha praktyka [Elektronnyy resurs]. – Rezhym dostupu: https://www.dls.gov.ua/wp-content/uploads/2020/05/Nastanova-ST-N-MOZU-42-4.0_2020.pdf.