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Informationen zum Autor Feroz jameel, PhD, is Principal Scientist for Drug Product Process Development at Amgen, involved in the development of biopharmaceutical products and the develop-ment of new technologies to enhance drug product manufacturing. Dr. Jameel is the recipient of the Parenteral Drug Association's 1999 Fred Simon Award for the Best Paper Published in the PDA Journal of Pharmaceutical Science and Technology. SUSAN HERSHENSON, PhD, is Vice President for Pharmaceutical and Device Development at Genentech. She has more than fifteen years' experience in the area of formulation and delivery, including development of protein and small molecule therapeutics. Klappentext A real-world guide to the production and manufacturing of biopharmaceuticals While much has been written about the science of biopharmaceuticals, there is a need for practical, up-to-date information on key issues at all stages of developing and manufacturing commercially viable biopharmaceutical drug products. This book helps fill the gap in the field, examining all areas of biopharmaceuticals manufacturing, from development and formulation to production and packaging. Written by a group of experts from industry and academia, the book 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 Formulation and Process Development Strategies for Manufacturing Biopharma-ceuticals is an essential resource for scientists and engineers in the pharmaceutical and biotech industries, for government and regulatory agencies, and for anyone with an interest in the latest developments in the field. Zusammenfassung Because pharmaceutical scientists lack information about biopharmaceutical product manufacture and commercialization! this book comprehensively covers fundamentals and essential pathways for each production phase; as well as the purpose! function! and relation to other stages in the product development process. Inhaltsverzeichnis Introduction ( John Carpenter ). Part I Preformulation and Development of Stability Indicating Assays: Biophysical Characterization Techniques. 1. The Structure of Biological Therapeutics ( Sherry Martin-Moe, Y. John Wang, Tim Osslund, Tahir Mahmood, Rohini Deshpande, and Susan Hershenson ). 2. Chemical Instability in Peptide and Protein Pharmaceuticals ( Elizabeth M. Topp, Lei Zhang, Hong Zhao, Robert W. Payne, Gabriel J. Evans and Mark Cornell Manning ). 3. Physical Instability in Peptide and Protein Pharmaceuticals ( Byeong Chang and Bernice Yang ). 4. Immunogenicity of Therapeutic Proteins ( Steven J Swanson ). 5. Preformulation Research: Assessing Protein Solution Behavior Early During Therapeutic Development ( Bernardo Perez-Ramirez, Nicholas Guziewicz and Robert Simler ). 6. Formulation Development of Phase I/II Biopharmaceuticals: An Efficient and Timely Approach ( Nicholas W. Warne ). 7. Late Stage Formulation Development and Characterization of Biopharmaceuticals ( Adeolla O Grillo ). 8. An Empirical Phase Diagram/ High Throughput Screening Approach to the Characterization and Formulation of Biopharmaceuticals ( Sangeeta B. Joshi; Akhilesh Bhambhani; Yuhong Zeng; and C. Russell Middaugh ). 9. Fluorescence and Phosphorescence Methods to Pro...
