Pharmaceutical Biotechnology: Fundamentals and Applications
- Lecture Notes, Study Materials and Important questions answers

Subject : Pharmaceutical Biotechnology: Fundamentals and Applications

Molecular Biotechnology

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

Biophysical and Biochemical Analysis of Recombinant Proteins

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

Production and Downstream Processing of Biotech Compounds

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

Formulation of Biotech Products Including Biopharmaceutical Considerations

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

Pharmacokinetics and Pharmacodynamics of Peptide and Protein Drugs

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

Immunogenicity of Therapeutic Proteins

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

Genomics Other Omics Technologies Personalized Medicine and Additional Biotechnology Related Techniques

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

Gene Therapy

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

Oligonucleotides

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

Hematopoietic Growth Factors

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

Interferons and Interleukins

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

Insulin

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

Growth Hormones

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

Recombinant Coagulation Factors and Thrombolytic Agents

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

Monoclonal Antibodies From Structure to Therapeutic Application

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

Monoclonal Antibodies in Cancer

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

Monoclonal Antibodies in Solid Organ Transplantation

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

Monoclonal Antibodies in Anti inflammatory Therapy

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

Recombinant Human Deoxyribonuclease I

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

Follicle

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

Vaccines

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

Dispensing Biotechnology Products Handling Professional Education and Product Information

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

Economic Considerations in Medical Biotechnology

1. Economic Considerations in Medical Biotechnology - Answer (click here)
2. The Value of a New Medical Technology - Answer (click here)
3. An Overview of Economic Analysis for New Technologies - Answer (click here)

Regulatory Issues and Drug Product Approval for Biopharmaceuticals

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