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Pharmaceutical Biotechnology: Fundamentals and Applications -

Pharmaceutical Biotechnology: Fundamentals and Applications

Molecular Biotechnology


-:- Molecular Biotechnology: Introduction
-:- The Cells: Prokaryotic Cell and Eukaryotic Cell
-:- Gene Expression
-:- DNA Replication
-:- Gene Transcription
-:- Gene Translation
-:- Recombinant DNA Technology
-:- DNA Transfer - Recombinant DNA Technology
-:- DNA Sources - Recombinant DNA Technology
-:- Production by Recombinant DNA Technology
-:- DNA Sequencing
-:- Genome Sequencing
-:- DNA Hybridization
-:- PCR Technology
-:- Cell Cultures: Cultivation of Microbes, Animal and Plant Cell Cultures

Biophysical and Biochemical Analysis of Recombinant Proteins


-:- Biophysical and Biochemical Analysis of Recombinant Proteins
-:- Protein Structure: Primary Structure
-:- Protein Structure: Secondary Structure
-:- Protein Structure: Tertiary Structure
-:- Protein Structure: Forces
-:- Protein Structure: Hydration
-:- Protein Folding
-:- Protein Stability
-:- Blotting Techniques - Proteins Analytical Techniques
-:- Immunoassays ELISA - Proteins Analytical Techniques
-:- Electrophoresis - Proteins Analytical Techniques
-:- Chromatography - Proteins Analytical Techniques
-:- Bioassays - Proteins Analytical Techniques
-:- Mass Spectrometry - Proteins Analytical Techniques

Production and Downstream Processing of Biotech Compounds


-:- Production and Downstream Processing of Biotech Compounds
-:- Expression Systems - Production of Biotech Compounds
-:- Cultivation Systems - Production of Biotech Compounds
-:- Cultivation Medium - Production of Biotech Compounds
-:- Contaminants - Production of Biotech Compounds
-:- Cellular DNA - Production of Biotech Compounds
-:- Downstream Processing of Biotech Compounds
-:- Filtration/Centrifugation - Downstream Processing of Biotech Compounds
-:- Precipitation - Downstream Processing of Biotech Compounds
-:- Chromatography - Downstream Processing of Biotech Compounds
-:- Issues to Consider in Production And purification of Proteins

Formulation of Biotech Products Including Biopharmaceutical Considerations


-:- Microbiological Considerations
-:- Excipients Used in Parenteral Formulations of biotech Products
-:- Solubility Enhancers - Excipients Used in Parenteral Formulations of biotech Products
-:- Anti Adsorption and Anti Aggregation Agents - Excipients Used in Parenteral Formulations of biotech Products
-:- Buffer Components - Excipients Used in Parenteral Formulations of biotech Products
-:- Preservatives and Antioxidants - Excipients Used in Parenteral Formulations of biotech Products
-:- Osmotic Agents - Excipients Used in Parenteral Formulations of biotech Products
-:- Shelf Life of Protein Based Pharmaceuticals - Excipients Used in Parenteral Formulations of biotech Products
-:- Freeze Drying of Proteins - Excipients Used in Parenteral Formulations of biotech Products
-:- Freezing - Excipients Used in Parenteral Formulations of biotech Products
-:- Primary Drying - Excipients Used in Parenteral Formulations of biotech Products
-:- Secondary Drying - Excipients Used in Parenteral Formulations of biotech Products
-:- Delivery of Proteins: Routes of Administration and Absorption Enhancement
-:- Delivery of Proteins: By The Parenteral Route
-:- Delivery of Proteins: Approaches For Rate Controlled Delivery
-:- Delivery of Proteins: Site Specific Delivery (Targeting) of Protein Drugs
-:- Anatomical, Physiological, and Pathological Considerations Relevant for Protein Targeting
-:- Soluble Carrier Systems for Targeted Delivery of Proteins
-:- Potential Pitfalls in Tumor Targeting
-:- Colloidal Particulate Carrier Systems for TargetedDelivery of Proteins: Nanotechnology at Work
-:- Perspectives for Targeted Protein Delivery

Pharmacokinetics and Pharmacodynamics of Peptide and Protein Drugs


-:- Pharmacokinetics and Pharmacodynamics of Peptide and Protein Drugs
-:- Pharmacokinetics of Protein Therapeutics
-:- Absorption of Protein Therapeutics - Pharmacokinetics of Protein Therapeutics
-:- Distribution of Protein Therapeutics - Pharmacokinetics of Protein Therapeutics
-:- Elimination of Protein Therapeutics - Pharmacokinetics of Protein Therapeutics
-:- Target Mediated Drug Disposition - Pharmacokinetics of Protein Therapeutics
-:- Immunogenicity and Protein Pharmacokinetics - Pharmacokinetics of Protein Therapeutics
-:- Species Specificity and Allometric Scaling - Pharmacokinetics of Protein Therapeutics
-:- Chemical Modifications for Optimizing the Pharmacokinetics of Protein Therapeutics - Pharmacokinetics of Protein Therapeutics
-:- Pharmacodynamics of Protein Therapeutics
-:- Direct Link PK/PD Models - Pharmacodynamics of Protein Therapeutics
-:- Indirect Link PK/PD Models - Pharmacodynamics of Protein Therapeutics
-:- Indirect Response PK/PD Models - Pharmacodynamics of Protein Therapeutics
-:- Cell Life Span Models - Pharmacodynamics of Protein Therapeutics
-:- Complex Response Models - Pharmacodynamics of Protein Therapeutics

Immunogenicity of Therapeutic Proteins


-:- Immunogenicity of Therapeutic Proteins
-:- The New Paradigm
-:- The Immunological Response
-:- Factors Influencing Antibody Formation Totherapeutic Proteins
-:- Assays for Antibodies
-:- Issues Specifically Related Tomonoclonal Antibodies
-:- Clinical Effects of Induced Antibodies
-:- Predicting and Reducing Immunogenicity

Genomics Other Omics Technologies Personalized Medicine and Additional Biotechnology Related Techniques


-:- Genomics, “Omics” Technologies, Personalized Medicine
-:- An Introduction to “Omics” Technologies
-:- Genomics - An Introduction to “Omics” Technologies
-:- “Omics” Enabling Technology: Bioinformatics
-:- Transcriptomics - An Introduction to “Omics” Technologies
-:- Proteomics, Structural Proteomics, and Functional Proteomics - “Omics” Technologies
-:- “Omics” Enabling Technology: Microarrays
-:- “Omics” Enabled Technology: BriefIntroduction to Biomarkers
-:- Metabonomics and Metabolomics
-:- Pharmacogenetics and Pharmacogenomics
-:- Toxicogenomics
-:- Glycomics and Glycobiology
-:- “Omics” Integrating Technology: Systems Biology
-:- Transgenic Animals
-:- Transgenic Plants
-:- Xenotransplantation: Transplantable Transgenic Animal Organs
-:- Knockout Mice
-:- Protein Engineering
-:- 3D Structures of Engineered Proteins
-:- Peptide Chemistry and Peptidomimetics
-:- Cell Therapy and Regenerative Medicine
-:- Stem Cells - Cell Therapy and Regenerative Medicine
-:- Tissue Engineering and Some Products of Tissue Engineering - Cell Therapy and Regenerative Medicine
-:- Biotechnology and Drug Discovery
-:- Screening and Synthesis - Biotechnology and Drug Discovery
-:- Chemical Genomics - Biotechnology and Drug Discovery

Gene Therapy


-:- Gene Therapy
-:- Ex Vivo Versus In Vivo Gene Therapy
-:- Gene Therapy in The Clinic: Disease Targets
-:- General Considerations - Vectors For Gene Transfer
-:- General Anatomy and Production of a Gene Transfer Vector
-:- Retroviral Vectors - Viral Vectors for Gene Transfer
-:- Adenoviral Vectors - Viral Vectors for Gene Transfer
-:- Adeno Associated Virus Vectors - Viral Vectors for Gene Transfer
-:- Non-Viral Vectors for Gene Transfer
-:- Construction of Non Viral Vectors
-:- Delivery Methods for Non-Viral Gene Transfer
-:- The Immune Response Against Non-Viral Vectors
-:- Clinical Use of Non-Viral Vectors
-:- Production and Processing of Non-Viral Vectors
-:- The Role of Drug Metabolism in Gene Therapy
-:- Gene Directed Enzyme Prodrug Therapy (GDEPT)
-:- Systems for Pharmacological Regulation of Gene Expression
-:- Regulation and Oversight of Gene Therapy Products

Oligonucleotides


-:- Oligonucleotides
-:- Interfering With Gene Expression - Oligonucleotides
-:- Triple Helix-Forming Oligonucleotides
-:- Transcription Factor Decoys - Oligonucleotides Interfering With Gene Expression
-:- Antisense/Ribozymes/EGS - Oligonucleotides Interfering With Gene Expression
-:- siRNA/miRNA - Oligonucleotides Interfering With Gene Expression
-:- Direct Binding to Non-Nucleic Acids
-:- Gene Repair
-:- Stimulating Immune Responses
-:- Pharmacokinetics of Oligonucleotide-Based Therapeutics
-:- Improving Oligonucleotide Stability
-:- Improving Cellular Uptake
-:- Diagnostic Applications

Hematopoietic Growth Factors


-:- Hematopoietic Growth Factors
-:- Hematopoiesis
-:- Chemical Description of Hematopoietic Growth Factors
-:- Chemical Properties and Marketing Information for the Myeloid Factors, G-CSF and GM-CSF
-:- Chemical Properties and Marketing Information for SCF
-:- Chemical Properties and Marketing Information for TPOs
-:- Pharmacology
-:- Pharmaceutical Issues
-:- Pharmacokinetics
-:- Pharmacodynamics
-:- Established Uses - Hematopoietic Growth Factors
-:- AIDS - Pharmaceutical Biotechnology
-:- Toxicities

Interferons and Interleukins


-:- Interferons and Interleukins
-:- Interferons: Nomenclature and Functions
-:- Interleukins: Nomenclature and Functions
-:- Rapeutic Use of Recombinant Interferons
-:- Therapeutic Use of Recombinant Interleukins
-:- Aldesleukin - Therapeutic Use of Recombinant Interleukins
-:- Oprelvekin - Therapeutic Use of Recombinant Interleukins
-:- Anakinra - Therapeutic Use of Recombinant Interleukins
-:- Pegylated Interferons and Interleukins: The Next Generation

Insulin


-:- Insulin
-:- Chemical Description of Insulin
-:- Pharmacology and Formulations of Insulin
-:- Regular and Rapid Acting Soluble Formulations - Pharmacology and Formulations of Insulin
-:- Intermediate Acting Insulin Formulations - Pharmacology and Formulations of Insulin
-:- Long Acting Insulin Formulations - Pharmacology and Formulations of Insulin
-:- Chemical Stability of Insulin Formulations
-:- Physical Stability of Insulin Formulations
-:- Clinical and Practice Aspects of Insulin

Growth Hormones


-:- Human growth hormone (hGH): Structure and Isohormones
-:- Growth Hormone Secretion and Regulation
-:- Growth Hormone Biologic Actions
-:- hGH Receptor and Binding Proteins
-:- Molecular Endocrinology and Signal Transduction
-:- Dosing Schedules and Routes of Human growth hormone (hGH)
-:- Pharmacokinetics and Metabolism
-:- Protein Manufacture, Formulation and Stability- Growth Hormones
-:- Clinical Usage of Human growth hormone (hGH)

Recombinant Coagulation Factors and Thrombolytic Agents


-:- Recombinant Coagulation Factors and Thrombolytic Agents
-:- Recombinant Coagulation Factors VIII
-:- Recombinant Coagulation Factor VIIA
-:- Recombinant Coagulation Factor IX
-:- Tissue Type Plasminogen Activator - Recombinant Thrombolytic Agents
-:- Recombinant t-PA (rt-PA; Alteplase) - First Generation Recombinant Thrombolytic Agents
-:- Second Generation Recombinant Thrombolytic Agents
-:- Reteplase - Second Generation Recombinant Thrombolytic Agents
-:- Tenecteplase - Thrombolytic Agents
-:- Lanoteplase - Thrombolytic Agents

Monoclonal Antibodies From Structure to Therapeutic Application


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

Monoclonal Antibodies in Cancer


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

Monoclonal Antibodies in Solid Organ Transplantation


-:- Monoclonal Antibodies in Solid Organ Transplantation
-:- Immunologic Targets: Rational Development/ Use of Monoclonal Antibodies in Organ Transplant
-:- Monoclonal Antibodies Administered Pre-Transplant
-:- Monoclonal Antibodies Administered at the Time of Transplant
-:- Monoclonal Antibodies Administered Following Transplant
-:- Muromonab - Specific Agents Used In Solid Organ Transplant
-:- Interleukin 2 Receptor Antagonists - Specific Agents Used In Solid Organ Transplant
-:- Alemtuzumab - Specific Agents Used In Solid Organ Transplant
-:- Rituximab - Specific Agents Used In Solid Organ Transplant

Monoclonal Antibodies in Anti inflammatory Therapy


-:- Monoclonal Antibodies in Anti inflammatory Therapy
-:- Arthritides - Monoclonal Antibodies in Anti inflammatory Therapy
-:- Infliximab - Arthritides - Monoclonal Antibodies in Anti inflammatory Therapy
-:- Etanercept - Arthritides - Monoclonal Antibodies in Anti inflammatory Therapy
-:- Adalimumab - Arthritides - Monoclonal Antibodies in Anti inflammatory Therapy
-:- Abatacept - Arthritides - Monoclonal Antibodies in Anti inflammatory Therapy
-:- Rituximab - Arthritides - Monoclonal Antibodies in Anti inflammatory Therapy
-:- Psoriasis: Efalizumab - Monoclonal Antibodies
-:- Multiple Sclerosis: Natalizumab - Monoclonal Antibodies in Anti inflammatory Therapy
-:- Allergic Asthma: Omalizumab - Monoclonal Antibodies in Anti inflammatory Therapy

Recombinant Human Deoxyribonuclease I


-:- Recombinant Human Deoxyribonuclease I
-:- Protein Chemistry, Enzymology, and Structure
-:- In Vitro Activity in CF Sputum - Pharmacology - Recombinant Human Deoxyribonuclease I
-:- In Vivo Activity in CF Sputum - Pharmacology - Recombinant Human Deoxyribonuclease I
-:- Pharmacokinetics and Metabolism - Pharmacology - Recombinant Human Deoxyribonuclease I
-:- Protein Manufacturing and Formulation
-:- Drug Delivery- Recombinant Human Deoxyribonuclease I
-:- Clinical Use- Recombinant Human Deoxyribonuclease I

Follicle


-:- Follicle Stimulating Hormone
-:- Biological Role of Follicle Stimulating Hormone
-:- Chemical Description of Follicle Stimulating Hormone
-:- Production of Recombinant FSH(Follicle Stimulating Hormone)
-:- Structural Characteristics of Isohormones - Follicle Stimulating Hormone
-:- Biological Properties of Recombinant FSH Isohormones
-:- Pharmacokinetic Behavior of Recombinant FSH Isohormones
-:- Pharmaceutical Formulations of Follicle Stimulating Hormone(FSH)
-:- Clinical Aspects of Follicle Stimulating Hormone(FSH)

Vaccines


-:- Vaccines
-:- Immunological Principles of Vaccines
-:- Active Immunization: Generation of an Immune Response
-:- Uptake - Immunological Principles of Vaccines
-:- Activation and Migration - Immunological Principles of Vaccines
-:- Antigen Presentation and Lymphocyte Activation
-:- Adaptive Immune System - Immunological Principles of Vaccines
-:- Vaccine Design in Relation with the Immune Response
-:- Route of Administration - Immunological Principles of Vaccines
-:- Conventional Vaccines: Classification
-:- Live Attenuated Vaccines
-:- Non-Living Vaccines: Whole Organisms, Subunit Vaccines
-:- Genetically Improved Live Vaccines
-:- Genetically Improved Subunit Vaccines
-:- Reverse Vaccinology
-:- Therapeutic Vaccines
-:- Pharmaceutical Aspects of Vaccines

Dispensing Biotechnology Products Handling Professional Education and Product Information


-:- Dispensing Biotechnology Products: Handling, Professional Education, and Product Information
-:- Pharmacist Reluctance
-:- Types of Information Needed by Pharmacists - Pharmacist Reluctance
-:- Sources of Information for Pharmacists
-:- The Pharmacist and Handling of Biotech Drugs
-:- Temperature Requirements - Pharmacist Reluctance
-:- Storage in Dosing and Administration Devices - Pharmacist Reluctance
-:- Storage in IV Solutions and Light Protection - Pharmacist Reluctance
-:- Mixing and Shaking - Pharmacist Reluctance
-:- Travel Requirements - Pharmacist Reluctance
-:- Preparation of Biotechnology Products
-:- Administration of Biotechnology Products
-:- Biogenerics - A Future Consideration?
-:- Outpatient/Home Care Issues of Biotechnology Products

Economic Considerations in Medical Biotechnology


-:- Economic Considerations in Medical Biotechnology
-:- The Value of a New Medical Technology
-:- An Overview of Economic Analysis for New Technologies

Regulatory Issues and Drug Product Approval for Biopharmaceuticals


-:- Regulatory Issues and Drug Product Approval for Biopharmaceuticals
-:- Background Regulatory Issues for Biopharmaceuticals
-:- Biosimilar and Follow-On Biologics
-:- Regulatory Routes - Biopharmaceuticals
Mahendra Varman Mahendra Varman Mahendra Varman Mahendra Varman Mahendra Varman

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