This handbook is an excellent reference for graduates and researchers in biotechnology and practitioners in the pharmaceutical industry who wish to develop a commercial chromatographic purification process. The authors guide readers through each step of the development process, beginning with basic chromatography theory and practice and incorporating examples from companies with established processes and approved biotherapeutics. They also cover properties of biological molecules, and reveal pitfalls often encountered in the process. Design strategies are discussed in depth, considering common starting materials and their impact on purification design, scale-up concerns, and validation. The authors use their extensive consulting and teaching experience to present a practical approach to developing an optimal chromatographic process, scaling it up, and meeting requirements set forth by regulatory agencies. The included diskette contains modeling exercises providing valuable insights into the influence of chromatographic parameters on separation results and the impact of process design on production costs, making the Handbook an excellent hands-on teaching tool.
Key Features
* Considers the entire scope of process chromatography, including scale up, regulatory issues, equipment, evaluation studies, scheduling, and cost-effectiveness
* Provides examples from companies with established processes and approved biotherapeutics
* Includes an appendix which lists the most pertinent regulatory documents, allowing the user to gather necessary information to comply with global regulatory expectations for process chromatography
* Contains a modeling program on the included disk
From the Back Cover
This Handbook offers a practical approach to developing an optimal chromatographic process, scaling it up, and adapting it to comply with requirements set by world-wide regulatory agencies.
The reader is led through every stage of the development process using examples from companies with established processes and approved biotherapeutics. The aim is to help the reader to realize the scope of issues that must be evaluated and avoid common pitfalls. For the uninitiated, separate chapters also deal with basic chromatography theory and properties of biological molecules.
The authors have used their extensive experience in teaching and consultancy to present a practical approach to the critical issue of validation. They have also compiled an appendix of the most pertinent regulatory documents. The accompanying disk contains modeling exercises providing valuable insight into the influence of chromatographic parameters on the separation result and the impact of process design on production costs.
The holistic and practical approach of the Handbook make it an essential reference for graduates and researchers in biochemical engineering and biotechnology as well as practitioners in the pharmaceutical industry. The enclosed disk also makes the Handbook an excellent hands-on teaching tool.
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