Biopharmaceuticals Manufacturing Handbook
from C.H.I.P.S.

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals
edited by Feroz Jameel

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals is a real-world guide to the production and manufacturing of biopharmaceuticals.

This book examines all areas of biopharmaceuticals manufacturing, from development and formulation to production and packaging. It focuses on real-world methods for maintaining product integrity throughout the commercialization process, clearly explaining the fundamentals and essential pathways for all development stages.

Coverage includes:

  • Research and early development phase–appropriate approaches for ensuring product stability
  • Development of commercially viable formulations for liquid and lyophilized dosage forms
  • Optimal storage, packaging, and shipping methods
  • Case studies relating to therapeutic monoclonal antibodies, recombinant proteins, and plasma fractions
  • Useful analysis of successful and failed products


Part I Preformulation and Development of Stability Indicating Assays: Biophysical Characterization Techniques

  1. The Structure of Biological Therapeutics
  2. Chemical Instability in Peptide and Protein Pharmaceuticals
  3. Physical Instability in Peptide and Protein Pharmaceuticals
  4. Immunogenicity of Therapeutic Proteins
  5. Preformulation Research: Assessing Protein Solution Behavior Early During Therapeutic Development
  6. Formulation Development of Phase I/II Biopharmaceuticals: An Efficient and Timely Approach
  7. Late Stage Formulation Development and Characterization of Biopharmaceuticals
  8. An Empirical Phase Diagram/ High Throughput Screening Approach to the Characterization and Formulation of Biopharmaceuticals
  9. Fluorescence and Phosphorescence Methods to Probe Protein Structure and Stability in Ice: the Case of Azurin
  10. Applications of Sedimentation Velocity Analytical Ultracentrifugation
  11. Field Flow Fractionation with Multi-angle Light Scattering for Measuring Particle Size of Virus-like Particles
  12. Light Scattering Techniques and their Application to Formulation and Aggregation Concerns

Part 2 Development of a Formulation for Liquid Dosage Form

  1. Efficient Approaches to Formulation Development of Biopharmaceuticals
  2. Prediction of Protein Aggregation Propensities from Primary Sequence Information
  3. High Concentration Antibody Formulations
  4. Development of Formulations for Therapeutic Monoclonal Antibodies and Fc Fusion Proteins
  5. Reversible Self-Association of Pharmaceutical Proteins: Characterization and Case Studies

Part 3 Development of Formulation for Lyophilized Dosage Form.

  1. Design of a Formulation for Freeze Drying
  2. Protein Conformation and Reactivity in Amorphous Solids
  3. The Impact of Buffer on Solid-State Properties and Stability of Freeze-Dried Dosage Forms
  4. Stabilization of Lyophilized Pharmaceuticals by Control of Molecular Mobility: Impact of Thermal History
  5. Structural Analysis of Proteins in Dried Matrices
  6. The Impact of Formulation and Drying Processes on the Characteristics and Performance of Biopharmaceutical Powders

Part 4 Manufacturing Sciences

  1. Manufacturing Fundamentals for Biopharmaceuticals
  2. Protein Stability during Bioprocessing
  3. Freezing and Thawing of Protein Solutions
  4. Strategies for Bulk Storage and Shipment of Proteins
  5. Drying Process Methods for Biopharmaceutical Products: An Overview
  6. Spray Drying of Biopharmaceuticals and Vaccines
  7. Development and Optimization of Freeze Drying Process
  8. Considerations for Successful Lyophilization Process Scale-up, Technology Transfer and Routine Production
  9. Process Robustness in Freeze-Drying of Biopharmaceuticals
  10. Filling Processes and Technologies for Liquid Biopharmaceuticals
  11. Leachables and Extractables
  12. Primary Container/Closure Selection for Biopharmaceuticals
  13. Pre-filled Syringes for Biopharmaceuticals
  14. Impact of Manufacturing Processes on the Drug Product Stability and Quality


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Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals
edited by Feroz Jameel
2010 • 955 pages • $174.00 + shipping
Texas residents please add 6.75 % sales tax

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