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Pharmaceutical Biotechnology: Fundamentals and Applications - Online Course

Pharmaceutical Biotechnology: Fundamentals and Applications - Medical Course Subject



Pharmaceutical Biotechnology: Fundamentals and Applications




Molecular Biotechnology


1. Molecular Biotechnology: Introduction
2. The Cells: Prokaryotic Cell and Eukaryotic Cell
3. Gene Expression
4. DNA Replication
5. Gene Transcription
6. Gene Translation
7. Recombinant DNA Technology
8. DNA Transfer - Recombinant DNA Technology
9. DNA Sources - Recombinant DNA Technology
10. Production by Recombinant DNA Technology
11. DNA Sequencing
12. Genome Sequencing
13. DNA Hybridization
14. PCR Technology
15. Cell Cultures: Cultivation of Microbes, Animal and Plant Cell Cultures



Biophysical and Biochemical Analysis of Recombinant Proteins


1. Biophysical and Biochemical Analysis of Recombinant Proteins
2. Protein Structure: Primary Structure
3. Protein Structure: Secondary Structure
4. Protein Structure: Tertiary Structure
5. Protein Structure: Forces
6. Protein Structure: Hydration
7. Protein Folding
8. Protein Stability
9. Blotting Techniques - Proteins Analytical Techniques
10. Immunoassays ELISA - Proteins Analytical Techniques
11. Electrophoresis - Proteins Analytical Techniques
12. Chromatography - Proteins Analytical Techniques
13. Bioassays - Proteins Analytical Techniques
14. Mass Spectrometry - Proteins Analytical Techniques



Production and Downstream Processing of Biotech Compounds


1. Production and Downstream Processing of Biotech Compounds
2. Expression Systems - Production of Biotech Compounds
3. Cultivation Systems - Production of Biotech Compounds
4. Cultivation Medium - Production of Biotech Compounds
5. Contaminants - Production of Biotech Compounds
6. Cellular DNA - Production of Biotech Compounds
7. Downstream Processing of Biotech Compounds
8. Filtration/Centrifugation - Downstream Processing of Biotech Compounds
9. Precipitation - Downstream Processing of Biotech Compounds
10. Chromatography - Downstream Processing of Biotech Compounds
11. Issues to Consider in Production And purification of Proteins



Formulation of Biotech Products Including Biopharmaceutical Considerations


1. Microbiological Considerations
2. Excipients Used in Parenteral Formulations of biotech Products
3. Solubility Enhancers - Excipients Used in Parenteral Formulations of biotech Products
4. Anti Adsorption and Anti Aggregation Agents - Excipients Used in Parenteral Formulations of biotech Products
5. Buffer Components - Excipients Used in Parenteral Formulations of biotech Products
6. Preservatives and Antioxidants - Excipients Used in Parenteral Formulations of biotech Products
7. Osmotic Agents - Excipients Used in Parenteral Formulations of biotech Products
8. Shelf Life of Protein Based Pharmaceuticals - Excipients Used in Parenteral Formulations of biotech Products
9. Freeze Drying of Proteins - Excipients Used in Parenteral Formulations of biotech Products
10. Freezing - Excipients Used in Parenteral Formulations of biotech Products
11. Primary Drying - Excipients Used in Parenteral Formulations of biotech Products
12. Secondary Drying - Excipients Used in Parenteral Formulations of biotech Products
13. Delivery of Proteins: Routes of Administration and Absorption Enhancement
14. Delivery of Proteins: By The Parenteral Route
15. Delivery of Proteins: Approaches For Rate Controlled Delivery
16. Delivery of Proteins: Site Specific Delivery (Targeting) of Protein Drugs
17. Anatomical, Physiological, and Pathological Considerations Relevant for Protein Targeting
18. Soluble Carrier Systems for Targeted Delivery of Proteins
19. Potential Pitfalls in Tumor Targeting
20. Colloidal Particulate Carrier Systems for TargetedDelivery of Proteins: Nanotechnology at Work
21. Perspectives for Targeted Protein Delivery



Pharmacokinetics and Pharmacodynamics of Peptide and Protein Drugs


1. Pharmacokinetics and Pharmacodynamics of Peptide and Protein Drugs
2. Pharmacokinetics of Protein Therapeutics
3. Absorption of Protein Therapeutics - Pharmacokinetics of Protein Therapeutics
4. Distribution of Protein Therapeutics - Pharmacokinetics of Protein Therapeutics
5. Elimination of Protein Therapeutics - Pharmacokinetics of Protein Therapeutics
6. Target Mediated Drug Disposition - Pharmacokinetics of Protein Therapeutics
7. Immunogenicity and Protein Pharmacokinetics - Pharmacokinetics of Protein Therapeutics
8. Species Specificity and Allometric Scaling - Pharmacokinetics of Protein Therapeutics
9. Chemical Modifications for Optimizing the Pharmacokinetics of Protein Therapeutics - Pharmacokinetics of Protein Therapeutics
10. Pharmacodynamics of Protein Therapeutics
11. Direct Link PK/PD Models - Pharmacodynamics of Protein Therapeutics
12. Indirect Link PK/PD Models - Pharmacodynamics of Protein Therapeutics
13. Indirect Response PK/PD Models - Pharmacodynamics of Protein Therapeutics
14. Cell Life Span Models - Pharmacodynamics of Protein Therapeutics
15. Complex Response Models - Pharmacodynamics of Protein Therapeutics



Immunogenicity of Therapeutic Proteins


1. Immunogenicity of Therapeutic Proteins
2. The New Paradigm
3. The Immunological Response
4. Factors Influencing Antibody Formation Totherapeutic Proteins
5. Assays for Antibodies
6. Issues Specifically Related Tomonoclonal Antibodies
7. Clinical Effects of Induced Antibodies
8. Predicting and Reducing Immunogenicity



Genomics Other Omics Technologies Personalized Medicine and Additional Biotechnology Related Techniques


1. Genomics, �Omics� Technologies, Personalized Medicine
2. An Introduction to �Omics� Technologies
3. Genomics - An Introduction to �Omics� Technologies
4. �Omics� Enabling Technology: Bioinformatics
5. Transcriptomics - An Introduction to �Omics� Technologies
6. Proteomics, Structural Proteomics, and Functional Proteomics - �Omics� Technologies
7. �Omics� Enabling Technology: Microarrays
8. �Omics� Enabled Technology: BriefIntroduction to Biomarkers
9. Metabonomics and Metabolomics
10. Pharmacogenetics and Pharmacogenomics
11. Toxicogenomics
12. Glycomics and Glycobiology
13. �Omics� Integrating Technology: Systems Biology
14. Transgenic Animals
15. Transgenic Plants
16. Xenotransplantation: Transplantable Transgenic Animal Organs
17. Knockout Mice
18. Protein Engineering
19. 3D Structures of Engineered Proteins
20. Peptide Chemistry and Peptidomimetics
21. Cell Therapy and Regenerative Medicine
22. Stem Cells - Cell Therapy and Regenerative Medicine
23. Tissue Engineering and Some Products of Tissue Engineering - Cell Therapy and Regenerative Medicine
24. Biotechnology and Drug Discovery
25. Screening and Synthesis - Biotechnology and Drug Discovery
26. Chemical Genomics - Biotechnology and Drug Discovery



Gene Therapy


1. Gene Therapy
2. Ex Vivo Versus In Vivo Gene Therapy
3. Gene Therapy in The Clinic: Disease Targets
4. General Considerations - Vectors For Gene Transfer
5. General Anatomy and Production of a Gene Transfer Vector
6. Retroviral Vectors - Viral Vectors for Gene Transfer
7. Adenoviral Vectors - Viral Vectors for Gene Transfer
8. Adeno Associated Virus Vectors - Viral Vectors for Gene Transfer
9. Non-Viral Vectors for Gene Transfer
10. Construction of Non Viral Vectors
11. Delivery Methods for Non-Viral Gene Transfer
12. The Immune Response Against Non-Viral Vectors
13. Clinical Use of Non-Viral Vectors
14. Production and Processing of Non-Viral Vectors
15. The Role of Drug Metabolism in Gene Therapy
16. Gene Directed Enzyme Prodrug Therapy (GDEPT)
17. Systems for Pharmacological Regulation of Gene Expression
18. Regulation and Oversight of Gene Therapy Products



Oligonucleotides


1. Oligonucleotides
2. Interfering With Gene Expression - Oligonucleotides
3. Triple Helix-Forming Oligonucleotides
4. Transcription Factor Decoys - Oligonucleotides Interfering With Gene Expression
5. Antisense/Ribozymes/EGS - Oligonucleotides Interfering With Gene Expression
6. siRNA/miRNA - Oligonucleotides Interfering With Gene Expression
7. Direct Binding to Non-Nucleic Acids
8. Gene Repair
9. Stimulating Immune Responses
10. Pharmacokinetics of Oligonucleotide-Based Therapeutics
11. Improving Oligonucleotide Stability
12. Improving Cellular Uptake
13. Diagnostic Applications



Hematopoietic Growth Factors


1. Hematopoietic Growth Factors
2. Hematopoiesis
3. Chemical Description of Hematopoietic Growth Factors
4. Chemical Properties and Marketing Information for the Myeloid Factors, G-CSF and GM-CSF
5. Chemical Properties and Marketing Information for SCF
6. Chemical Properties and Marketing Information for TPOs
7. Pharmacology
8. Pharmaceutical Issues
9. Pharmacokinetics
10. Pharmacodynamics
11. Established Uses - Hematopoietic Growth Factors
12. AIDS - Pharmaceutical Biotechnology
13. Toxicities



Interferons and Interleukins


1. Interferons and Interleukins
2. Interferons: Nomenclature and Functions
3. Interleukins: Nomenclature and Functions
4. Rapeutic Use of Recombinant Interferons
5. Therapeutic Use of Recombinant Interleukins
6. Aldesleukin - Therapeutic Use of Recombinant Interleukins
7. Oprelvekin - Therapeutic Use of Recombinant Interleukins
8. Anakinra - Therapeutic Use of Recombinant Interleukins
9. Pegylated Interferons and Interleukins: The Next Generation



Insulin


1. Insulin
2. Chemical Description of Insulin
3. Pharmacology and Formulations of Insulin
4. Regular and Rapid Acting Soluble Formulations - Pharmacology and Formulations of Insulin
5. Intermediate Acting Insulin Formulations - Pharmacology and Formulations of Insulin
6. Long Acting Insulin Formulations - Pharmacology and Formulations of Insulin
7. Chemical Stability of Insulin Formulations
8. Physical Stability of Insulin Formulations
9. Clinical and Practice Aspects of Insulin



Growth Hormones


1. Human growth hormone (hGH): Structure and Isohormones
2. Growth Hormone Secretion and Regulation
3. Growth Hormone Biologic Actions
4. hGH Receptor and Binding Proteins
5. Molecular Endocrinology and Signal Transduction
6. Dosing Schedules and Routes of Human growth hormone (hGH)
7. Pharmacokinetics and Metabolism
8. Protein Manufacture, Formulation and Stability- Growth Hormones
9. Clinical Usage of Human growth hormone (hGH)



Recombinant Coagulation Factors and Thrombolytic Agents


1. Recombinant Coagulation Factors and Thrombolytic Agents
2. Recombinant Coagulation Factors VIII
3. Recombinant Coagulation Factor VIIA
4. Recombinant Coagulation Factor IX
5. Tissue Type Plasminogen Activator - Recombinant Thrombolytic Agents
6. Recombinant t-PA (rt-PA; Alteplase) - First Generation Recombinant Thrombolytic Agents
7. Second Generation Recombinant Thrombolytic Agents
8. Reteplase - Second Generation Recombinant Thrombolytic Agents
9. Tenecteplase - Thrombolytic Agents
10. Lanoteplase - Thrombolytic Agents



Monoclonal Antibodies From Structure to Therapeutic Application


1. Monoclonal Antibodies: From Structure to Therapeutic Application
2. Antibody Structure and Classes
3. Murine, Chimeric, Humanized and Fully Humanized mAbs - Antibody Structure and Classes
4. Antibody Derivatives [F(ab0)2, Fab, Antibody DrugConjugates (ADC)] and Fusion Proteins
5. How Antibodies Function as Therapeutics
6. Translational Medicine/Development Process
7. Preclinical Safety Assessment of mAbs - Translational Medicine/Development Process
8. Pharmacokinetics - Translational Medicine/Development Process
9. Prediction of Human PK/PD Based on Preclinical Information
10. PK/PD in Clinical Development of Antibody Therapeutics
11. Mechanistic Modeling Approaches - Translational Medicine/Development Process
12. Population PK of Monoclonal Antibodies



Monoclonal Antibodies in Cancer


1. Monoclonal Antibodies in Cancer
2. Alemtuzumab - Classes of Monoclonal Antibodies: CD Antigens
3. Gemtuzumab - Monoclonal Antibodies in Cancer
4. Rituximab, Yttrium-90 (90Y) Ibritumomab Tiuxetan, Iodine-131 (131I) Tositumomab
5. Bevacizumab - Classes of Monoclonal Antibodies: Vascular Endothelial Growth Factor Inhibitors
6. Trastuzumab - Classes of Monoclonal Antibodies: Endothelial Growth Factor Receptor (EGFR) Inhibitors
7. Cetuximab - Classes of Monoclonal Antibodies: Endothelial Growth Factor Receptor (EGFR) Inhibitors
8. Panitumumab - Classes of Monoclonal Antibodies: Endothelial Growth Factor Receptor (EGFR) Inhibitors



Monoclonal Antibodies in Solid Organ Transplantation


1. Monoclonal Antibodies in Solid Organ Transplantation
2. Immunologic Targets: Rational Development/ Use of Monoclonal Antibodies in Organ Transplant
3. Monoclonal Antibodies Administered Pre-Transplant
4. Monoclonal Antibodies Administered at the Time of Transplant
5. Monoclonal Antibodies Administered Following Transplant
6. Muromonab - Specific Agents Used In Solid Organ Transplant
7. Interleukin 2 Receptor Antagonists - Specific Agents Used In Solid Organ Transplant
8. Alemtuzumab - Specific Agents Used In Solid Organ Transplant
9. Rituximab - Specific Agents Used In Solid Organ Transplant



Monoclonal Antibodies in Anti inflammatory Therapy


1. Monoclonal Antibodies in Anti inflammatory Therapy
2. Arthritides - Monoclonal Antibodies in Anti inflammatory Therapy
3. Infliximab - Arthritides - Monoclonal Antibodies in Anti inflammatory Therapy
4. Etanercept - Arthritides - Monoclonal Antibodies in Anti inflammatory Therapy
5. Adalimumab - Arthritides - Monoclonal Antibodies in Anti inflammatory Therapy
6. Abatacept - Arthritides - Monoclonal Antibodies in Anti inflammatory Therapy
7. Rituximab - Arthritides - Monoclonal Antibodies in Anti inflammatory Therapy
8. Psoriasis: Efalizumab - Monoclonal Antibodies
9. Multiple Sclerosis: Natalizumab - Monoclonal Antibodies in Anti inflammatory Therapy
10. Allergic Asthma: Omalizumab - Monoclonal Antibodies in Anti inflammatory Therapy



Recombinant Human Deoxyribonuclease I


1. Recombinant Human Deoxyribonuclease I
2. Protein Chemistry, Enzymology, and Structure
3. In Vitro Activity in CF Sputum - Pharmacology - Recombinant Human Deoxyribonuclease I
4. In Vivo Activity in CF Sputum - Pharmacology - Recombinant Human Deoxyribonuclease I
5. Pharmacokinetics and Metabolism - Pharmacology - Recombinant Human Deoxyribonuclease I
6. Protein Manufacturing and Formulation
7. Drug Delivery- Recombinant Human Deoxyribonuclease I
8. Clinical Use- Recombinant Human Deoxyribonuclease I



Follicle


1. Follicle Stimulating Hormone
2. Biological Role of Follicle Stimulating Hormone
3. Chemical Description of Follicle Stimulating Hormone
4. Production of Recombinant FSH(Follicle Stimulating Hormone)
5. Structural Characteristics of Isohormones - Follicle Stimulating Hormone
6. Biological Properties of Recombinant FSH Isohormones
7. Pharmacokinetic Behavior of Recombinant FSH Isohormones
8. Pharmaceutical Formulations of Follicle Stimulating Hormone(FSH)
9. Clinical Aspects of Follicle Stimulating Hormone(FSH)



Vaccines


1. Vaccines
2. Immunological Principles of Vaccines
3. Active Immunization: Generation of an Immune Response
4. Uptake - Immunological Principles of Vaccines
5. Activation and Migration - Immunological Principles of Vaccines
6. Antigen Presentation and Lymphocyte Activation
7. Adaptive Immune System - Immunological Principles of Vaccines
8. Vaccine Design in Relation with the Immune Response
9. Route of Administration - Immunological Principles of Vaccines
10. Conventional Vaccines: Classification
11. Live Attenuated Vaccines
12. Non-Living Vaccines: Whole Organisms, Subunit Vaccines
13. Genetically Improved Live Vaccines
14. Genetically Improved Subunit Vaccines
15. Reverse Vaccinology
16. Therapeutic Vaccines
17. Pharmaceutical Aspects of Vaccines



Dispensing Biotechnology Products Handling Professional Education and Product Information


1. Dispensing Biotechnology Products: Handling, Professional Education, and Product Information
2. Pharmacist Reluctance
3. Types of Information Needed by Pharmacists - Pharmacist Reluctance
4. Sources of Information for Pharmacists
5. The Pharmacist and Handling of Biotech Drugs
6. Temperature Requirements - Pharmacist Reluctance
7. Storage in Dosing and Administration Devices - Pharmacist Reluctance
8. Storage in IV Solutions and Light Protection - Pharmacist Reluctance
9. Mixing and Shaking - Pharmacist Reluctance
10. Travel Requirements - Pharmacist Reluctance
11. Preparation of Biotechnology Products
12. Administration of Biotechnology Products
13. Biogenerics - A Future Consideration?
14. Outpatient/Home Care Issues of Biotechnology Products



Economic Considerations in Medical Biotechnology


1. Economic Considerations in Medical Biotechnology
2. The Value of a New Medical Technology
3. An Overview of Economic Analysis for New Technologies



Regulatory Issues and Drug Product Approval for Biopharmaceuticals


1. Regulatory Issues and Drug Product Approval for Biopharmaceuticals
2. Background Regulatory Issues for Biopharmaceuticals
3. Biosimilar and Follow-On Biologics
4. Regulatory Routes - Biopharmaceuticals




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