Handbook of Process Chromatography 2nd Edition: Development, Manufacturing, Validation and Economics by Lars Hagel, Günter Jagschies and Gail K. Sofer will tie that experience together for the next generation of readers. Updates include sources and productivity, types of products made today, experiences in clinical and licensed products, economics, current status of validation, illustrations and tables, automated column packing and automated systems.
In Chapter 1, authors address the state of the biopharmaceutical industry today. This sets the stage for the subsequent chapters. Much has changed. For example, the whole concept of follow-on products, generic approaches and platform technologies were not even topics of interest when the first edition of this book was published.
Chapter 2 describes process capability from the perspective of several functional depart-ments, the market needs for biopharmaceuticals and some production setups for manufacturing at different scales during the various stages of development and production. The ability of mammalian cell and microbial substrates to meet the future market demands is explored and the use of multi-product facilities described.
Chapter 3 presents process design concepts that enable development of a process suitable for manufacturing biotherapeutics. We discuss, among other topics, the importance of risk assessments, the design of a logical purification strategy and characterization studies. Expression systems used to produce biopharmaceuticals, with an emphasis on the most commonly used hosts, E. coli and CHO, are discussed in terms of productivity and types of products made today.
Separation technologies that are discussed in Chapter 4 include both chroniatography and filtration. An overview of currently used recovery steps is followed by a discussion on basic chromatography techniques and their optimization and scale-up. In Chapter 5, in-process and final product analytical methods are presented. Specific analytical tools applied to monoclonal antibodies and nucleic acid products, such as DNA plasmids, are described. Process analytical technologies (PAT), method validation, setting specifications and the use of standards are also addressed.
Chapter 6 addresses the always-important issues of cleaning and sanitization of chromatography resins, reusable filters and equipment. This chapter is followed by validation (Chapter 7), which includes cleaning validation for chromatography columns. An appendix to the Chapter 7 provides a summary of activities from pre-clinical to post-licensure for biopharmaceutical production from genetically engineered mammalian cells. Current validation trends, which are discussed, may influence future validation costs.
The final two chapters address chromatographic equipment and column packing. New equipment designs, improved automation and pack-in-place columns are discussed. Appendices with detailed references for nomenclature of liquid chromatography, reduced numbers used in process engineering, validation activities during development and the simulation tutorial complete the content of this book.
More details about this book...
or
Download Handbook of Process Chromatography PDF Ebook :
