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Table of Contents
Intro; Preface; Contents; About the Author; Chapter 1: Principles of Recombinant DNA Technology; Introduction; Production Methods; Cloning and Recombinant DNA Technology; Molecular Cloning and Subsequent Protein Production by Fermentation Tank or Biopharming; Polymerase Chain Reaction; Chemical Modification of Products; Purification Technology; Characterization; Bioassays; Immunoassays; Electrophoresis; Ultraviolet/Visible Spectroscopy; Fluorescence; Circular Dichroism; Vibrational Spectroscopy; Mass Spectrometry; Light Scattering; Calorimetry; High Performance Liquid Chromatography.
Analysis and RegulationSummary Points; References; Chapter 2: Therapeutic Proteins; Introduction: Protein/Peptide Structure and What That Means for Delivery; Delivery Challenges; Instability; Physical Instabilities; Thermal Denaturation; Mechanical Denaturation; Adsorption; Chemical Instabilities; Hydrolysis; Deamidation; Oxidation; Low Permeability across Biological Membranes; Immunogenicity and Its Effect on Drug Efficacy; Bioavailability in General; Potential Methods of Delivery; Oral Delivery; Injectable Delivery; Pulmonary Delivery; Nasal Delivery; Oromucosal Delivery.
Transdermal DeliveryTopical Delivery; Summary Points; References; Chapter 3: Therapeutic Antibodies; Introduction; Antibody Structure; Monoclonal Antibody Nomenclature; Monoclonal Antibody Types; Murine; Chimeric; Humanized; Human; Pharmacologic Effect; Drug Development and Antibody Engineering; Fc Engineering; Fusion Proteins and Antibody Fragments; Antibody Conjugates; Bispecific Antibodies; Alternative Protein Scaffolds; Pharmacokinetics of Monoclonal Antibodies; Absorption; Distribution; Antibody Metabolism and Elimination; Delivery Methods; Clinical Applications.
Antibody-Specific Adverse EffectsCytokine Release Syndrome and Other Potentially Fatal Infusion Reactions; Tumor Lysis Syndrome; Infection; Severe Mucocutaneous Reactions; Malignancies; Cardiotoxicity; Therapeutic Areas; Organ Transplant Prophylaxis; Cancer; Autoimmune Disorders; Miscellaneous Conditions; Previously Marketed Monoclonal Antibodies; Monoclonal Antibodies Currently in Development; Summary Points; References; Chapter 4: Analysis and Regulation of Biologics, Including Biosimilars; Introduction; FD & C Section 505(b)(2) and the Products That Currently May Be Approved Via This Pathway.
PHS Act/Biologics Price Competition and Innovation (BCPI) Act of 2009Innovator Biologics Approval; Biosimilar Pathway; Totality of the Evidence; Interchangeability; Product Switching; Product Naming; Marketplace Uptake; Summary Points; References; Glossary; Index.
Analysis and RegulationSummary Points; References; Chapter 2: Therapeutic Proteins; Introduction: Protein/Peptide Structure and What That Means for Delivery; Delivery Challenges; Instability; Physical Instabilities; Thermal Denaturation; Mechanical Denaturation; Adsorption; Chemical Instabilities; Hydrolysis; Deamidation; Oxidation; Low Permeability across Biological Membranes; Immunogenicity and Its Effect on Drug Efficacy; Bioavailability in General; Potential Methods of Delivery; Oral Delivery; Injectable Delivery; Pulmonary Delivery; Nasal Delivery; Oromucosal Delivery.
Transdermal DeliveryTopical Delivery; Summary Points; References; Chapter 3: Therapeutic Antibodies; Introduction; Antibody Structure; Monoclonal Antibody Nomenclature; Monoclonal Antibody Types; Murine; Chimeric; Humanized; Human; Pharmacologic Effect; Drug Development and Antibody Engineering; Fc Engineering; Fusion Proteins and Antibody Fragments; Antibody Conjugates; Bispecific Antibodies; Alternative Protein Scaffolds; Pharmacokinetics of Monoclonal Antibodies; Absorption; Distribution; Antibody Metabolism and Elimination; Delivery Methods; Clinical Applications.
Antibody-Specific Adverse EffectsCytokine Release Syndrome and Other Potentially Fatal Infusion Reactions; Tumor Lysis Syndrome; Infection; Severe Mucocutaneous Reactions; Malignancies; Cardiotoxicity; Therapeutic Areas; Organ Transplant Prophylaxis; Cancer; Autoimmune Disorders; Miscellaneous Conditions; Previously Marketed Monoclonal Antibodies; Monoclonal Antibodies Currently in Development; Summary Points; References; Chapter 4: Analysis and Regulation of Biologics, Including Biosimilars; Introduction; FD & C Section 505(b)(2) and the Products That Currently May Be Approved Via This Pathway.
PHS Act/Biologics Price Competition and Innovation (BCPI) Act of 2009Innovator Biologics Approval; Biosimilar Pathway; Totality of the Evidence; Interchangeability; Product Switching; Product Naming; Marketplace Uptake; Summary Points; References; Glossary; Index.