Introduction to Biologic and Biosimilar Product Development and Analysis

Abstract

The purpose of this book is to give a concise introduction to development and analysis of pharmaceutical biologics for those in the pharmaceutical industry who are switching focus from small molecules to biologics processing, analysis, and delivery. In order to maintain a limited focus, Introduction to Biologic and Biosimilar Product Development and Analysis, will deal only with peptides, proteins and monoclonal antibodies. 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.