By Feroz Jameel, Susan Hershenson
A real-world advisor to the construction and production of biopharmaceuticals
While a lot has been written in regards to the technology of biopharmaceuticals, there's a want for useful, up to date info on key concerns in any respect phases of constructing and production commercially possible biopharmaceutical drug items. This e-book is helping fill the distance within the box, reading all components of biopharmaceuticals production, from improvement and formula to creation and packaging.
Written through a bunch of specialists from and academia, the ebook makes a speciality of real-world tools for preserving product integrity during the commercialization procedure, sincerely explaining the basics and crucial pathways for all improvement phases. assurance contains:
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Research and early improvement phase?appropriate techniques for making sure product stability
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Development of commercially conceivable formulations for liquid and lyophilized dosage forms
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Optimal garage, packaging, and transport methods
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Case reviews when it comes to healing monoclonal antibodies, recombinant proteins, and plasma fractions
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Useful research of winning and failed products
Formulation and method improvement concepts for production Biopharma-ceuticals is a necessary source for scientists and engineers within the pharmaceutical and biotech industries, for presidency and regulatory enterprises, and for someone with an curiosity within the most up-to-date advancements within the field.Content:
Chapter 1 The constitution of organic Therapeutics (pages 1–40): Sheryl Martin?Moe, Tim Osslund, Y. John Wang, Tahir Mahmood, Rohini Deshpande and Susan Hershenson
Chapter 2 Chemical Instability in Peptide and Protein prescription drugs (pages 41–67): Elizabeth M. Topp, Lei Zhang, Hong Zhao, Robert W. Payne, Gabriel J. Evans and Mark Cornell Manning
Chapter three actual balance of Protein prescribed drugs (pages 69–104): Byeong S. Chang and Bernice Yeung
Chapter four Immunogenicity of healing Proteins (pages 105–117): Steven J. Swanson
Chapter five Preformulation learn: Assessing Protein resolution habit in the course of Early improvement (pages 119–146): Bernardo Perez?Ramirez, Nicholas Guziewicz and Robert Simler
Chapter 6 formula improvement of part 1–2 Biopharmaceuticals: a good and well timed method (pages 147–159): Nicholas W. Warne
Chapter 7 Late?Stage formula improvement and Characterization of Biopharmaceuticals (pages 161–171): Adeola O. Grillo
Chapter eight An Empirical part Diagram–High?Throughput Screening method of the Characterization and formula of Biopharmaceuticals (pages 173–205): Sangeeta B. Joshi, Akhilesh Bhambhani, Yuhong Zeng and C. Russell Middaugh
Chapter nine Fluorescence and Phosphorescence ways to Probe Protein constitution and balance in Ice: The Case of Azurin (pages 207–229): Giovanni B. Strambini
Chapter 10 functions of Sedimentation pace Analytical Ultracentrifugation (pages 231–251): Tom Laue
Chapter eleven box move Fractionation with Multiangle mild Scattering for Measuring Particle dimension Distributions of Virus?Like debris (pages 253–268): Joyce A. Sweeney and Christopher Hamm
Chapter 12 Light?Scattering thoughts and their software to formula and Aggregation issues (pages 269–305): Michael Larkin and Philip Wyatt
Chapter thirteen powerful methods to formula improvement of Biopharmaceuticals (pages 307–328): Rajiv Nayar and Mitra Mosharraf
Chapter 14 Prediction of Aggregation Propensity from basic series details (pages 329–347): Mark Cornell Manning, Gabriel J. Evans, Cody M. Van Pelt and Robert W. Payne
Chapter 15 High?Concentration Antibody Formulations (pages 349–381): Steven J. Shire, Jun Liu, Wolfgang Friess, Susanne Jorg and Hanns?Christian Mahler
Chapter sixteen improvement of Formulations for healing Monoclonal Antibodies and Fc Fusion Proteins (pages 383–427): Sampathkumar Krishnan, Monica M. Pallitto and Margaret S. Ricci
Chapter 17 Reversible Self?Association of Pharmaceutical Proteins: Characterization and Case stories (pages 429–455): Vikas ok. Sharma, Harminder Bajaj and Devendra S. Kalonia
Chapter 18 layout of a formula for Freeze Drying (pages 457–492): Feroz Jameel and Mike J. Pikal
Chapter 19 Protein Conformation and Reactivity in Amorphous Solids (pages 493–506): Lei Zhang, Sandipan Sinha and Elizabeth M. Topp
Chapter 20 The effect of Buffer on Solid?State homes and balance of Freeze?Dried Dosage kinds (pages 507–519): Evgenyi Y. Shalaev and Larry A. Gatlin
Chapter 21 Stabilization of Lyophilized prescribed drugs by means of regulate of Molecular Mobility: influence of Thermal background (pages 521–548): Suman Luthra and Michael J. Pikal
Chapter 22 Structural research of Proteins in Dried Matrices (pages 549–563): Andrea Hawe, Sandipan Sinha, Wolfgang Friess and Wim Jiskoot
Chapter 23 The influence of formula and Drying procedures at the features and function of Biopharmaceutical Powders (pages 565–585): Vu L. Truong and Ahmad M. Abdul?Fattah
Chapter 24 production basics for Biopharmaceuticals (pages 587–604): Maninder Hora
Chapter 25 Protein balance in the course of Bioprocessing (pages 605–624): Mark Cornell Manning, Gabriel J. Evans and Robert W. Payne
Chapter 26 Freezing and Thawing of Protein ideas (pages 625–675): Satish okay. Singh and Sandeep Nema
Chapter 27 techniques for Bulk garage and cargo of Proteins (pages 677–704): Feroz Jameel, Chakradhar Padala and Theodore W. Randolph
Chapter 28 Drying technique tools for Biopharmaceutical items: an summary (pages 705–738): Ahmad M. Abdul?Fattah and Vu L. Truong
Chapter 29 Spray Drying of Biopharmaceuticals and Vaccines (pages 739–761): Jim Searles and Govindan Mohan
Chapter 30 improvement and Optimization of the Freeze?Drying methods (pages 763–796): Feroz Jameel and Jim Searles
Chapter 31 concerns for profitable Lyophilization technique Scale?Up, know-how move, and regimen construction (pages 797–826): Samir U. Sane and Chung C. Hsu
Chapter 32 technique Robustness in Freeze Drying of Biopharmaceuticals (pages 827–837): D. Q. Wang, D. MacLean and X. Ma
Chapter 33 Filling methods and applied sciences for Liquid Biopharmaceuticals (pages 839–856): Ananth Sethuraman, Xiaogang Pan, Bhavya Mehta and Vinay Radhakrishnan
Chapter 34 Leachables and Extractables (pages 857–880): Jim Castner, Pedro Benites and Michael Bresnick
Chapter 35 basic box and Closure choice for Biopharmaceuticals (pages 881–896): Olivia Henderson
Chapter 36 Prefilled Syringes for Biopharmaceuticals (pages 897–916): Robert Swift
Chapter 37 impression of producing approaches on Drug Product balance and caliber (pages 917–940): Nitin Rathore, Rahul S. Rajan and Erwin Freund