{"product_id":"formulation-and-process-development-strategies-for-manufacturing-biopharmaceuticals-hardback-9780470118122","title":"Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals (Hardback) 9780470118122","description":"\u003cfont face=\"Georgia\"\u003e\r\n\u003cp\u003e\u003cfont size=\"6\"\u003eFormulation and Process Development Strategies for Manufacturing Biopharmaceuticals\u003c\/font\u003e\u003cbr\u003e\r\n\r\n\r\n\r\n\r\n\r\n\u003c\/p\u003e\n\u003cp\u003e\u003cfont size=\"4\"\u003eFeroz Jameel (Edited by), F Jameel (Author), Susan Hershenson (Edited by)\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e9780470118122, Wiley\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003eHardback, published 10 September 2010\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e984 pages\u003cbr\u003e23.9 x 16.3 x 5.8 cm, 1.406 kg\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\r\n\u003cp align=\"justify\"\u003e\u003cem\u003e\u003cfont size=\"3\"\u003e\"This book is intended as a comprehensive look at the growing area of producing and manufacturing biopharmaceuticals, right the way through from development to commercialisation. Each chapter is written by an expert in that area and authors hail from both industry and academia.\" (TCE- The Chemical Engineer, 1 December 2010)\u003cbr\u003e\u003c\/font\u003e\u003c\/em\u003e\u003c\/p\u003e\r\n\r\n\u003cp align=\"justify\"\u003e\u003cstrong\u003e\u003cfont size=\"3\"\u003e\u003cp\u003eA real-world guide to the production and manufacturing of biopharmaceuticals\u003c\/p\u003e \u003cp\u003eWhile 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.\u003c\/p\u003e \u003cp\u003eWritten 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:\u003c\/p\u003e \u003cul\u003e \u003cli\u003e \u003cp\u003eResearch and early development phase–appropriate approaches for ensuring product stability\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eDevelopment of commercially viable formulations for liquid and lyophilized dosage forms\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eOptimal storage, packaging, and shipping methods\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eCase studies relating to therapeutic monoclonal antibodies, recombinant proteins, and plasma fractions\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eUseful analysis of successful and failed products\u003c\/p\u003e \u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003eFormulation 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.\u003c\/p\u003e\u003c\/font\u003e\u003c\/strong\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e\u003cb\u003eIntroduction\u003c\/b\u003e (\u003ci\u003eJohn Carpenter\u003c\/i\u003e).  \u003cp\u003e\u003cb\u003ePart I Preformulation and Development of Stability Indicating Assays: Biophysical Characterization Techniques.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e1. The Structure of Biological Therapeutics (\u003ci\u003eSherry Martin-Moe, Y. John Wang, Tim Osslund, Tahir Mahmood, Rohini Deshpande, and Susan Hershenson\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e2. Chemical Instability in Peptide and Protein Pharmaceuticals (\u003ci\u003eElizabeth M. Topp, Lei Zhang, Hong Zhao, Robert W. Payne, Gabriel J. Evans and Mark Cornell Manning\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e3. Physical Instability in Peptide and Protein Pharmaceuticals (\u003ci\u003eByeong Chang and Bernice Yang\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e4. Immunogenicity of Therapeutic Proteins (\u003ci\u003eSteven J Swanson\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e5. Preformulation Research: Assessing Protein Solution Behavior Early During Therapeutic Development (\u003ci\u003eBernardo Perez-Ramirez, Nicholas Guziewicz and Robert Simler\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e6. Formulation Development of Phase I\/II Biopharmaceuticals: An Efficient and Timely Approach (\u003ci\u003eNicholas W. Warne\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e7. Late Stage Formulation Development and Characterization of Biopharmaceuticals (\u003ci\u003eAdeolla O Grillo\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e8. An Empirical Phase Diagram\/ High Throughput Screening Approach to the Characterization and Formulation of Biopharmaceuticals (\u003ci\u003eSangeeta B. Joshi; Akhilesh Bhambhani; Yuhong Zeng; and C. Russell Middaugh\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e9. Fluorescence and Phosphorescence Methods to Probe Protein Structure and Stability in Ice: the Case of Azurin (\u003ci\u003eGiovanni Strambini\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e10. Applications of Sedimentation Velocity Analytical Ultracentrifugation (\u003ci\u003eTom Laue\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e11. Field Flow Fractionation with Multi-angle Light Scattering for Measuring Particle Size of Virus-like Particles (\u003ci\u003eJoyce A Sweeney and Christopher Hamm\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e12. Light Scattering Techniques and their Application to Formulation and Aggregation Concerns (\u003ci\u003ePhilip Wyatt and Michael Larkin\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart 2 Development of a Formulation for Liquid Dosage Form.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e13. Efficient Approaches to Formulation Development of Biopharmaceuticals (\u003ci\u003eRajiv Nayar and Mitra Mosharraf\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e14. Prediction of Protein Aggregation Propensities from Primary Sequence Information (\u003ci\u003eMark Cornell Manning, Gabriel J. Evans, Cody M. Van Pelt and Robert W. Payne\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e15. High Concentration Antibody Formulations (\u003ci\u003eSteven J. Shire, Jun Liu, Wolfgang Friess, Susanne Matheus and Hanns-Christian Mahler\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e16. Development of Formulations for Therapeutic Monoclonal Antibodies and Fc Fusion Proteins (\u003ci\u003eSampath kumar Krishnan, Monica M. Pallitto and Margaret S. Ricci\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e17. Reversible Self-Association of Pharmaceutical Proteins: Characterization and Case Studies (\u003ci\u003eVikas K. Sharma, Harminder Bajaj and Devendra S. Kalonia\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart 3 Development of Formulation for Lyophilized Dosage Form.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e18. Design of a Formulation for Freeze Drying (\u003ci\u003eFeroz Jameel and Mike J. Pikal\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e19. Protein Conformation and Reactivity in Amorphous Solids (\u003ci\u003eLei Zhang, Sandipan Sinha and Elizabeth M. Topp\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e20. The Impact of Buffer on Solid-State Properties and Stability of Freeze-Dried Dosage Forms (\u003ci\u003eEvgenyi Y. Shalaev and Larry A. Gatlin\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e21. Stabilization of Lyophilized Pharmaceuticals by Control of Molecular Mobility: Impact of Thermal History (\u003ci\u003eSuman Luthra and Micheal J. Pikal\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e22. Structural Analysis of Proteins in Dried Matrices (\u003ci\u003eAndrea Hawe, Sandipan Sinha, Wolfgang Friess and Wim Jiskoot\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e23. The Impact of Formulation and Drying Processes on the Characteristics and Performance of Biopharmaceutical Powders (\u003ci\u003eVu L. Truong and Ahmad M. Abdul-Fattah\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart 4 Manufacturing Sciences.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e24. Manufacturing Fundamentals for Biopharmaceuticals (\u003ci\u003eManinder Hora\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e25. Protein Stability during Bioprocessing (\u003ci\u003eMark Cornell Manning, Gabriel J. Evans and Robert W. Payne\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e26. Freezing and Thawing of Protein Solutions (\u003ci\u003eSatish Singh and Sandeep Neema\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e27. Strategies for Bulk Storage and Shipment of Proteins (\u003ci\u003eFeroz Jameel, Chakradhar Padala and Theodore W. Randolph\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e28. Drying Process Methods for Biopharmaceutical Products: An Overview (\u003ci\u003eAhmad M. Abdul-Fattah and Vu L. Truong\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e29. Spray Drying of Biopharmaceuticals and Vaccines (\u003ci\u003eJim Searles and Govindan (Dan) Mohan\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e30. Development and Optimization of Freeze Drying Process (\u003ci\u003eFeroz Jameel and Jim Searles\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e31. Considerations for Successful Lyophilization Process Scale-up, Technology Transfer and Routine Production (\u003ci\u003eSamir Sane and Chung C. Hsu\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e32. Process Robustness in Freeze-Drying of Biopharmaceuticals (\u003ci\u003eD.Q. Wang, D. MacLean and X. Ma\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e33. Filling Processes and Technologies for Liquid Biopharmaceuticals (\u003ci\u003eAnanth Sethuraman, Xiaogang Pan, Bhavya Mehta and Vinay Radhakrishnan\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e34. Leachables and Extractables (\u003ci\u003eJim Castner, Pedro Benites and Michael Bresnick\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e35. Primary Container\/Closure Selection for Biopharmaceuticals (\u003ci\u003eOlivia Henderson\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e36. Pre-filled Syringes for Biopharmaceuticals (\u003ci\u003eRobert Swift and Robin Hwang\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e37. Impact of Manufacturing Processes on the Drug Product Stability and Quality (\u003ci\u003eNitin Rathore, Rahul S. Rajan and Erwin Freund\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003eIndex.\u003c\/p\u003e\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003eSubject Areas: Chemistry [\u003ca title=\"See our other books on Chemistry\" href=\"https:\/\/freshlyprintedbooks.co.uk\/search?q=%22Chemistry%20%5BPN%5D%22\"\u003ePN\u003c\/a\u003e]\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\u003c\/font\u003e","brand":"Wiley","offers":[{"title":"Brand New","offer_id":52257074053400,"sku":"9780470118122","price":130.89,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0730\/2037\/5320\/files\/9780470118122.jpg?v=1781276295","url":"https:\/\/freshlyprintedbooks.co.uk\/products\/formulation-and-process-development-strategies-for-manufacturing-biopharmaceuticals-hardback-9780470118122","provider":"Freshly Printed Books","version":"1.0","type":"link"}