TYPE OF COURSE UNIT	Elective Course
LEVEL OF COURSE UNIT	Bachelor's Degree
YEAR OF STUDY	-
SEMESTER	-
NUMBER OF ECTS CREDITS ALLOCATED	2
NAME OF LECTURER(S)	Professor Miyase Nilüfer Tarımcı Professor Fatma Nevin Çelebi
LEARNING OUTCOMES OF THE COURSE UNIT	At the end of this course, the students; 1) Learns the basic concepts in biotechnology, properties of biotechnological products. 2) Learn about the production process of products produced with recombinant, monoclonal and hybridoma technology. 3) Gains knowledge of the problems encountered in the formulations of biotechnological products and their solutions. 4) Learns the processes of developing biosimilar products. 5) Learn regulation of biosimilar products in the world and Turkey. 6) Acquire knowledge about duties, rights and responsibilities; and act ethically and in compliance with regulations as an individual. 7) Have knowledge about the ability to use the knowledge and skills gained in the advanced stages of education and to use them in professional life.
MODE OF DELIVERY	Face to face
PRE-REQUISITES OF THE COURSE	No
RECOMMENDED OPTIONAL PROGRAMME COMPONENT	None
COURSE DEFINITION	This course covers the basic concepts in Pharmaceutical Biotechnology, the production processes of biotechnological products with recombinant DNA, monoclonal antibody and hybridoma technology, the production process and processes in the development of biosimilar products, and their legal regulations.
COURSE CONTENTS	WEEK TOPICS 1st Week Overview of Pharmaceutical Biotechnology: Properties and classifications of biotechnological products 2nd Week Products produced with recombinant DNA technology, products approved by FDA and EMA 3rd Week Products produced with monoclonal antibody and hybridoma technology, products approved by FDA and EMA 4th Week Properties, physical and chemical stability of peptides and proteins 5th Week Production processes of biotechnological products 6th Week Formulations of biotechnological products 7th Week MID TERM EXAMINATION 8th Week Pharmacokinetics of biotechnological products 9th Week Biotechnological vaccines (rDNA, mRNA vaccines) 10th Week Biosimilar products; Definitions in terms of FDA, EMA, WHO and TITCK, The status of biosimilars in the world and Turkey 11th Week Development of biosimilar products, production processes 12th Week Comparability studies in the development of biosimilar products 13th Week Legal regulations in biosimilar products 14th Week Stability and storage of biotech products
RECOMENDED OR REQUIRED READING	1. Lecturer notes 2. Pharmaceutical Biotechnology. Ed: Daan JA Crommelin, Taylor&Francis Group, FL USA, 2002. 3. Protein Formulation and Delivery, Ed: J Eugene J Mc Nally, Taylor&Francis Group, FL USA 2007 4. Pharmaceutical Biotechnology: Drug Discovery and Clinical Applications, Ed. Oliver Kayser, Wiley VCH , Germany 2012.
PLANNED LEARNING ACTIVITIES AND TEACHING METHODS	Lecture,Discussion
ASSESSMENT METHODS AND CRITERIA	Quantity Percentage(%) Mid-term 1 40 Total(%) 40 Contribution of In-term Studies to Overall Grade(%) 40 Contribution of Final Examination to Overall Grade(%) 60 Total(%) 100
ECTS WORKLOAD	Activities Number Hours Workload Midterm exam 1 2 2 Preparation for Quiz 0 0 0 Individual or group work 14 1 14 Preparation for Final exam 1 8 8 Course hours 14 2 28 Preparation for Midterm exam 1 6 6 Laboratory (including preparation) 0 0 0 Final exam 1 2 2 Homework 1 5 5 Total Workload 65 Total Workload / 30 2,16 ECTS Credits of the Course 2
LANGUAGE OF INSTRUCTION	Turkish
WORK PLACEMENT(S)	No