Course Code and Title:

EFB 600-01 Special Topics-1

Course Instructor(s):

Prof. Dr. Mutlu AYTEMİR

Course Type:

Compulsory

Course Content:

1) Ability to conduct a literature review related to the thesis topic; 2) Ability to organize information based on the literature and develop a data collection tool;
3) Ability to collect research data; 4) Ability to analyze data; 5) Ability to tabulate and interpret research findings; 6) Ability to draw conclusions from research findings and make recommendations; 7) Ability to report on the research and defend it.

Course Code and Name:

EFB 600-02 Special Topics-2

Course Instructor(s):

Prof. Dr. Mutlu AYTEMİR

Course Type:

Compulsory

Course Content:

1) Conducting a literature review related to the thesis topic; 2) Organizing information based on the literature and developing a data collection tool;
3) Collecting research data; 4) Analyzing data; 5) Presenting research findings in tables and interpreting them; 6) Drawing conclusions from research findings and making recommendations; 7) Preparing a research report and defending the research.

Course Code and Name:

EFB 610 Seminar

Course Instructor(s):

Prof. Dr. Turgut Emrah BOZKURT

Course Type:

Compulsory

Course Content:

Reviewing and evaluating scientific articles on a specific topic in the field of pharmaceutical biotechnology, preparing and presenting a seminar.

Course Code and Name:

EFB 650 Design of Dosage Forms with Proteins and Peptides I

Course Instructor(s):

Assoc. Prof. Dr. Kıvılcım SEYHUN – Assoc. Prof. Dr. Yağmur AKDAĞ ÇAYLI

Course Type:

Compulsory

Course Content:

Structural properties of proteins and peptides, separation, purification, and characterization techniques, physical and chemical stability, preformulation studies and formulation design in peptide and protein drugs, conventional dosage forms, biosimilar drugs and comparability, drug carrier nanosystems in commercial preparations, drugs in preclinical and clinical research phases, ethical and bioethical principles in clinical research, drugs used in clinical treatment and their controls

Course Code and Title:

EFB 612 Immunopharmaceuticals

Course Instructor(s):

Prof. Dr. Pınar Ülfet ERKEKOĞLU - Prof. Dr. Turgut Emrah BOZKURT - Assoc. Prof. Dr. Kıvılcım SEYHUN

Course Type:

Elective

Course Content:

Immune system, active and passive immunity, polyclonal and monoclonal antibodies, small modular immunopharmaceuticals, traditional and new vaccines, vaccine adjuvants

Course Code and Name:

EFB 620 Molecular Biotechnology

Course Instructor(s):

Prof. Dr. Pınar Ülfet ERKEKOĞLU

Course Type:

Elective

Course Content:

Molecular biotechnology, nucleic acids, genetic code and protein synthesis, gene expression, gene manipulation, gene cloning, gene transfer methods, protein engineering and directed mutagenesis, RNA technologies, hybridization methods, polymerase chain reaction, antisense technology, RNA interference, molecular diagnostics, omics technologies, drug-biomarker discovery in pharmaceutical biotechnology-development, pharmacogenomics, basic approaches in bioinformatics, bioinformatics applications in molecular biotechnology and pharmaceutical biotechnology, systems biology, biological databases, biological networks, data mining, information technologies, and statistics

Course Code and Name:

EFB 641 Targeting Techniques in Pharmaceutical Biotechnology

Course Instructor(s):

Assoc. Prof. Dr. Kıvılcım SEYHUN – Dr. Şükrü ÖZTÜRK

Course Type:

Elective

Course Content:

General information on targeted drug delivery systems, drug targeting techniques, active targeting, passive (natural) targeting, targeting via cell surface receptors, drug targeting of DNA and RNA in pharmaceutical biotechnology, targeting of genes using drug delivery systems, the role of nanotechnology in drug targeting, and targeting with monoclonal antibodies.

Course Code and Title:

EFB 658 Fundamentals of Pharmaceutical Biotechnology

Course Instructor(s):

Prof. Dr. Pınar Ülfet ERKEKOĞLU

Course Type:

Elective

Course Content:

Peptide and protein drugs produced using recombinant DNA technology (including monoclonal antibodies), production of vaccines and drugs prepared using nucleic acids, analytical methods, stability, and examples of pharmaceutical biotechnology products used in human health.

Course Code and Name:

EFB 680 Medical Devices, Combination Products, and Combined Advanced Therapy Medical Products in Pharmaceutical Biotechnology: Good Practices, Ethics, and Legal Regulations

Course Instructor(s):

Prof. Dr. Pınar Ülfet ERKEKOĞLU - Dr. Şükrü ÖZTÜRK

Course Type:

Elective

Course Content:

Pharmaceuticals (medical products), medical devices, biological medical products, biotechnological/biological drugs, advanced therapy medical products (ATMPs) (somatic cell therapy medical products, gene therapy medical products, tissue engineering products), ADTP combined with medical devices, biotechnological/biological drug-medical device combination products, gene and genetic tests, biological material derived from human or animal sources ( ), biomaterials, nanomaterials, scaffolds, cells, stem cells, and tissues, good practices, personalized medicines, quality assurance, national and international legal regulations, licensing, monitoring processes and systems, vigilance, biovigilance, pharmacovigilance, contract research organizations, approved organizations, clinical trials, their application in treatment, ethical and bioethical principles, the place and importance of knowledge and skills gained in pharmaceutical biotechnology in the field of medical devices

Course Code and Title:

EFB 685 Advanced Therapeutic Products: Gene, Cell, and Tissue Engineering, Quality Assurance, and Good Manufacturing Practices

Course Instructor(s):

Prof. Dr. Pınar Ülfet ERKEKOĞLU - Dr. Şükrü ÖZTÜRK

Course Type:

Elective

Course Content:

Genetic technologies, gene-tissue-cell engineering, advanced therapies, stem cell therapies, basic concepts at ITU, regenerative medicine, regenerative drugs, historical developments, biomaterials, nanomaterials, scaffolds, micro-nano carrier systems (microparticles, nanoparticles, liposomes, and lipid-based systems), cell-biomaterials interactions, model systems, analyses, cell immobilization-encapsulation, tissue-cell engineering, bioreactors, industrial production, stem cells, stem cells at ITU (adult, embryonic, and induced pluripotent) cells, cell engineering and regenerative medicine applications, cell and tissue engineering and ITU, R&D studies, good manufacturing practices, quality assurance, quality control, analyses, legal regulations, gene-tissue-cell engineering, advanced therapeutic medical products, regenerative medicine, regenerative drugs, personalized medicine, preclinical and clinical research, good clinical practices, ethics, bioethics, biosafety

Course Code and Title:

EFB 700-01 Special Topics

Course Instructor(s):

Prof. Dr. Mutlu AYTEMİR

Course Type:

Compulsory

Course Content:

1) Determination of the thesis topic; 2) Conducting a literature review on the thesis topic both domestically and internationally; 3) Planning all aspects of the research; 4) Developing the data collection tool; 5) Conducting validity and reliability studies on the data collection tool; 6) Implementing the data collection tool and evaluating the findings; 7) Reporting the research results.

Course Code and Name:

EFB 700-02 Special Topics

Course Instructor(s):

Prof. Dr. Mutlu AYTEMİR

Course Type:

Compulsory

Course Content:

1. Determining the thesis topic 2. Conducting a literature review on the thesis topic both domestically and internationally 3. Planning all aspects of the research 4. Developing the data collection tool 5. Conducting validity and reliability studies on the data collection tool 6. Implementing the data collection tool and evaluating the findings 7. Reporting the research results and defending the thesis

Course Code and Name:

EFB 700-03 Special Topics

Course Instructor(s):

Prof. Dr. Mutlu AYTEMİR

Course Type:

Compulsory

Course Content:

1. Determining the thesis topic 2. Conducting a literature review on the thesis topic both domestically and internationally 3. Planning all aspects of the research 4. Developing the data collection tool 5. Conducting validity and reliability studies on the data collection tool 6. Implementing the data collection tool and evaluating the findings 7. Reporting the research results and defending the thesis

Course Code and Name:

EFB 700-04 Special Topics

Course Instructor(s):

Prof. Dr. Mutlu AYTEMİR

Course Type:

Compulsory

Course Content:

1. Determining the thesis topic 2. Conducting a literature review on the thesis topic both domestically and internationally 3. Planning all aspects of the research 4. Developing the data collection tool 5. Conducting validity and reliability studies on the data collection tool 6. Implementing the data collection tool and evaluating the findings 7. Reporting the research results and defending the thesis

Course Code and Name:

EFB 711 Seminar

Course Instructor(s):

Prof. Dr. Mutlu AYTEMİR

Course Type:

Compulsory

Course Content:

Reviewing and evaluating scientific articles on a specific topic in the field of pharmaceutical biotechnology, preparing and presenting a seminar.

Course Code and Title:

EFB 720 Pharmaceutical Biotechnology-Derived Biological Drugs, Quality Assurance, Good Manufacturing Practices, and Licensing

Course Instructor(s):

Prof. Dr. Turgut Emrah BOZKURT

Course Type:

Compulsory

Course Content:

Pharmaceutical biotechnology-derived biological medical products, recombinant proteins, vaccines, biosimilar drugs, advanced therapy medical products (ATMPs) (somatic cell therapy medical products, gene therapy medical products, tissue engineering medical products, combined ATMPs), stem cells (embryonic, adult, and induced pluripotent stem cells) and stem cell-derived drugs, biotechnology-derived biological drug-device or drug combination products, bioprocess technologies, bioreactors and optimization, purification, good manufacturing practices, analyses, validations, quality controls, pharmaceutical quality assurance system, quality risk management, risk-based licensing, good practices, patent rights, applications in treatment, safety, pharmacovigilance, biovigilance, vigilance, preclinical research and clinical studies, good clinical practices, ethics, bioethics, biosafety, R&D strategies in biotechnology, policies, personalized medicines, orphan drugs, regenerative medicines, innovative medicines derived from pharmaceutical biotechnology

Course Code and Name:

EFB 730 Research Techniques and Laboratory Methods in Pharmaceutical Biotechnology

Course Instructor(s):

Prof. Dr. Mutlu AYTEMİR

Course Type:

Elective

Course Content:

Research techniques in pharmaceutical biotechnology, access to information, information technology databases, literature review, information management, pharmaceutical biotechnology laboratory methods, safe working principles, biosafety, good laboratory practices, pharmaceutical biotechnology laboratory equipment (autoclave, centrifuges, ultracentrifuges, incubators, electrophoresis devices, spectrophotometers, ELISA, imaging, and others) and their applications, protein analyses, blotting, DNA analyses, pDNA enzyme analyses, purity and quantity determination, particle size and distribution analysis, microscopic analyses, pharmacopeia analyses

Course Code and Name:

EFB 753 Cell and Gene Therapy Products, Legal Regulations and Quality Assurance in Advanced Therapy Medical Products

Course Instructor(s):

Prof. Dr. Pınar Ülfet ERKEKOĞLU - Prof. Dr. Turgut Emrah BOZKURT - Dr. Şükrü ÖZTÜRK

Course Type:

Elective

Course Content:

Biotechnological/biological drugs, cell, stem cell, gene therapy products, advanced therapy medicinal products (ATMPs) (somatic cell therapy medicinal products, gene therapy medicinal products, tissue engineering medicinal products, combined ATMPs), drug-device combination products, their characteristics, classifications, biotechnological/biological drug specifications, medical device specifications, quality assurance (good manufacturing practices, quality control, quality risk management), efficacy, safety, pharmacovigilance, biovigilance, vigilance, monitoring, tracking systems, global (EU countries, EMA, EC, FDA, ICH, ISO, and others), regulatory authorities, contract research and manufacturing organizations, compliance with regulatory requirements, clinical trials, ethical/bioethical principles, risk-based licensing, pharmacopoeias, good practices, good distribution practices, good clinical practices, good pharmacovigilance practices, reimbursement systems, and current developments.

Course Code and Title:

EFB 754  Biosimilar Medicines: Regulatory Framework for Comparability, Quality Assurance, Efficacy, and Safety

Course Instructor(s):

Prof. Dr. Pınar Ülfet ERKEKOĞLU - Prof. Dr. Turgut Emrah BOZKURT

Course Type:

Elective

Course Content:

Biosimilar drugs (similar biological medicinal products, biosimilar medicinal products), biosimilarity and comparability, biosimilar drug production, quality assurance, quality, efficacy, and safety, comparability studies, naming, immunogenicity, comparability in pharmaceutical biotechnology-derived biological medicinal products (recombinant proteins, advanced therapy medicinal products, stem cell-derived drugs, and stem cell-derived advanced therapy medicinal products, and others), pharmacovigilance, monitoring systems, national and international legal regulations (EC, EMA, EU, FDA, ICH, WHO, Pharmacopoeias), clinical trials, ethical and bioethical principles, approval, and biosimilar drugs used in treatment, guidelines specific to biosimilar drugs

Course Code and Title:

EFB 755 Cell and Tissue Culture: Laboratory Methods and Good Cell Culture Practices in Pharmaceutical Biotechnology

Course Instructor(s):

Dr. Şükrü ÖZTÜRK

Course Type:

Elective

Course Content:

Principles of safe working practices and biosafety in pharmaceutical biotechnology cell culture laboratories, good cell culture practices, ethics, bioethical principles, cell and tissue culture laboratory equipment, their characteristics and applications, mammalian cells, stem cells (adult, embryonic, induced pluripotent), primary cultures, cell lines, human and animal-derived cell-tissues, legal, ethical, and bioethical principles, cryopreservation, viability tests, cell-biomaterials-nanomaterials interactions, biocompatibility, analyses, functional tests, gene, tissue, and cell engineering, cell immobilization and encapsulation, electrophysiological measurements, cellular protein and nucleic acid analyses and pharmacopeia tests, gene manipulation techniques, genetically modified cells, microorganisms, anionic and cationic nanocarrier systems (liposomes, nanoparticles), complex preparation, encapsulation, controls, and transfection

Course Code and Name:

EFB 760  Design of Dosage Forms with Proteins and Peptides II

Course Instructor(s):

Assoc. Prof. Dr. Kıvılcım SEYHUN – Assoc. Prof. Dr. Yağmur AKDAĞ ÇAYLI

Course Type:

Elective

Course Content:

Peptide and protein-based drugs, definitions, classification, nomenclature, overview of legal regulations, pharmacokinetic properties, enzymatic and cellular barriers, absorption, distribution, metabolism, and elimination (ADME), formulation strategies, conventional dosage forms, controlled release systems, drug carrier nanosystems, chemical modification, pegylation technologies, antibody-drug conjugates, formulation and controlled release system design specific to different routes of administration (oral, parenteral, ocular, intraocular, transdermal, transmucosal, pulmonary, and others) formulation and controlled release system design, combination products with medical devices, implants, inserts, iontophoresis systems, active and passive targeting, applications in regenerative medicine, protein-based biosimilar biological drugs, comparability, immunogenicity, patent rights

Course Code and Title:

EFB 770 Lipids, Phospholipids, and Applications in Biotechnology

Course Instructor(s):

Prof. Dr. Mutlu AYTEMİR

Course Type:

Elective

Course Content:

Properties of lipids and phospholipids, their stability, cell membrane lipids, biological functions, isolation from natural sources, applications of lipids and phospholipids in biotechnology and pharmaceutical biotechnology, chemical modification of peptides and protein drugs or other drugs with lipids and phospholipids, chemical modification of lipids and phospholipids with polymers, lipids-phospholipids and nanostructures, drug-gene delivery systems, lipid-networks, lipid-derived drug and gene delivery systems (liposomes, polymer-coated liposomes, virosomes, vesicular phospholipid gels, nanostructured solid lipid nanoparticles, liquid crystals, microvesicles, and exosomes), lipids and phospholipids, polymorphism and interactions, biological distribution, pharmacokinetics (ADME), endocytosis, exocytosis, other transport mechanisms, toxicity, lipid analysis, lipidomics, systems biology, databases, omics technologies, bioinformatics, current developments

Course Code and Name:

EFB 785 Pharmaceutical Biotechnology: Supramolecular Structures in Drug, Gene, and Cellular Carrier System Design

Course Instructor(s):

Assoc. Prof. Dr. Kıvılcım SEYHUN

Course Type:

Elective

Course Content:

Pharmaceutical biotechnology, self-assembly, supramolecular (SM) structures, liquid crystals, amphiphilic molecules, anionic and cationic lipids, polymers, peptides), nucleic acids (DNA, siRNA, pDNA, RNA), SM structures, complex formation with nucleic acids, transfection, drug and gene delivery system design, liposomes, nanoparticles, solid lipid nanoparticles, virosomes, exosomes, micelles, liquid crystals, characterization, analytical methods, cellular carrier systems, fate in biological systems, biological distribution, pharmacokinetic properties, immunogenicity, toxicity, nanotoxicology, drug, gene, and cellular carrier systems in preclinical and clinical research, nanomaterials, biomaterials, biological materials, synthetic components, nanocarrier systems, target tissues and organs, drug-gene-based carrier systems in preclinical and clinical research phases, good manufacturing practices, clinical trials, legal, ethical, and bioethical principles

Course Code and Title:

EFB 799 Preparation for the Doctoral Qualification Exam

Course Instructor(s):

Prof. Dr. Mutlu AYTEMİR

Course Type:

Compulsory

Course Content:

Individual study required to pass the doctoral qualification exam

Course Code and Title:

EFB 800 Research Studies Related to Thesis I

Course Instructor(s):

Prof. Dr. Mutlu AYTEMİR

Course Type:

Elective

Course Content:

The doctoral student, in collaboration with their advisor, identifies research topics and conducts detailed readings and discussions on these topics to prepare a comprehensive review.

Course Code and Name:

EFB 801 Research Studies Related to Thesis II

Course Instructor(s):

Prof. Dr. Mutlu AYTEMİR

Course Type:

Compulsory

Course Content:

The course involves the doctoral student, in collaboration with their advisor, identifying appropriate research topics, formulating a suitable hypothesis related to these topics, determining the most appropriate research protocol to test this hypothesis, and preparing an ethical committee application in accordance with the established guidelines.

Course Code and Title:

EFB 802 Research Studies Related to the Thesis III

Course Instructor(s):

Prof. Dr. Mutlu AYTEMİR

Course Type:

Compulsory

Course Content:

Preparing a project proposal for funding and conducting preliminary work to develop a research protocol aligned with the hypotheses established by the doctoral student and their advisor regarding their chosen research topics.