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Handbook of Process Chromatography
Gail K. SoferLars Hagel
其他書名
A Guide to Optimization, Scale Up, and Validation
出版Elsevier Science, 1997-06-24
主題Science / Life Sciences / MicrobiologyMedical / GeneralScience / BiotechnologyScience / Chemistry / AnalyticScience / Life Sciences / BiochemistryScience / Life Sciences / BiophysicsScience / Life Sciences / GeneralScience / Life Sciences / BiologyScience / Chemistry / Industrial & TechnicalSocial Science / Sociology / General
ISBN012654266X9780126542660
URLhttp://books.google.com.hk/books?id=YakvAQAAIAAJ&hl=&source=gbs_api
註釋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.