Pharmaceutical Biotechnology: Fundamentals and Applications

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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



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