Pharmaceutical Biotechnology: Fundamentals and Applications

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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



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