Current Trends in Monoclonal Antibody Development and Manufacturing

ISBN: 978-0-387-76642-3 (Print) 978-0-387-76643-0 (Online)

Table of contents (19 chapters)

  1. Front Matter

    Pages i-xiv

  2. Design Of Therapeutic MABS

    1. Front Matter

      Pages 8-8

    2. No Access

      Book Chapter

      Pages 1-5

      Introduction

    3. No Access

      Book Chapter

      Pages 9-28

      CDR Repair: A Novel Approach to Antibody Humanization

    4. No Access

      Book Chapter

      Pages 29-48

      Nanobodies, Single-Domain Antigen-Binding Fragments of Camelid Heavy-Chain Antibodies

  3. Expression and Production of MABS

    1. Front Matter

      Pages 50-50

    2. No Access

      Book Chapter

      Pages 51-62

      GPEx® A Flexible Method for the Rapid Generation of Stable, High Expressing, Antibody Producing Mammalian Cell Lines

    3. No Access

      Book Chapter

      Pages 63-72

      Advancing Our Cell Culture Platform: Incorporating Lessons Learned and New Technologies

  4. Recovery and Purification

    1. Front Matter

      Pages 74-74

    2. No Access

      Book Chapter

      Pages 75-85

      Addressing Changes Associated with Technology Transfer: A Case Study

    3. No Access

      Book Chapter

      Pages 87-99

      Concepts for Disposables in Biopharmaceutical Manufacture

  5. Formulation and Delivery

    1. Front Matter

      Pages 102-102

    2. No Access

      Book Chapter

      Pages 103-129

      Formulation and Delivery Issues for Monoclonal Antibody Therapeutics

    3. No Access

      Book Chapter

      Pages 131-147

      Challenges in the Development of High Protein Concentration Formulations

    4. No Access

      Book Chapter

      Pages 149-175

      Protein Immobilization by Crystallization and Precipitation: An Alternative to Lyophilization

  6. Analytics and Specification Setting for MABS

    1. Front Matter

      Pages 178-178

    2. No Access

      Book Chapter

      Pages 179-192

      Characterizing High Affinity Antigen/Antibody Complexes by Kinetic and Equilibrium Based Methods

    3. No Access

      Book Chapter

      Pages 193-205

      Analytical Characterization of Monoclonal Antibodies: Linking Structure to Function

    4. No Access

      Book Chapter

      Pages 207-227

      Analysis of Irreversible Aggregation, Reversible Self-association and Fragmentation of Monoclonal Antibodies by Analytical Ultracentrifugation

    5. No Access

      Book Chapter

      Pages 229-246

      Biophysical Signatures of Monoclonal Antibodies

  7. Pharmacokinetics and Immunogenicity

    1. Front Matter

      Pages 248-248

    2. No Access

      Book Chapter

      Pages 249-269

      Impact of Fc Glycosylation on Monoclonal Antibody Effector Functions and Degradation by Proteases

    3. No Access

      Book Chapter

      Pages 271-291

      Immunogenicity Assessment of Antibody Therapeutics

  8. Armed Antibodies and New Classes of Antibodies

    1. Front Matter

      Pages 294-294

    2. No Access

      Book Chapter

      Pages 295-308

      Production of Monoclonal Antibodies in E. coli

    3. No Access

      Book Chapter

      Pages 309-322

      Recent Advancements in the Use of Antibody Drug Conjugates for Cancer Therapy

    4. No Access

      Book Chapter

      Pages 323-344

      Antibody Radiolabeling

  9. Back Matter

    Pages 345-351