Introduction to biologic and biosimilar product development and analysis. ([2018])

• Record Type: Book
• Further Information: Note: Karen M. Nagel.
• Authors: Nagel, Karen
• 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
• Publisher Details: Cham, Switzerland : Springer
• Publication Date: 2018
• Extent: 1 online resource
• Subjects: 615.19; Medicine; Drug development; Biologicals; MEDICAL / Pharmacology; Medical -- Pharmacy; Pharmacy / dispensing; Pharmaceutical technology; Pharmacy; Pharmaceutical technology; Electronic books
• Languages: English
• ISBNs: 9783319984285; 3319984284
• Related ISBNs: 9783319984278; 3319984276
• Notes: Note: Includes bibliographical references.; Note: Online resource; title from PDF title page (EBSCO, viewed October 2, 2018).
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.