biotechnology: a comprehensive training guide for the biotechnology industry

ISBN-13: 9781420084481 / Angielski / Miękka / 2009 / 868 str.

Syed Imtiaz Haider; Anika Ashok

Opis

All manufacturing companies face the daunting task of designing an employee training matrix that meets the gamut of national and international regulatory standards. Answering the call for a one-stop training resource that focuses exclusively on this multi-faceted, high-tech industry, Biotechnology: A Comprehensive Training Guide for the Biotechnology Industry provides ready-to-implement training templates that save time and expense without cutting corners on critical elements. Attached CD-ROM: Why Reinvent the Wheel? This complete, single-source reference contains 28 complete biotechnology courses and a customizable CD-ROM with hands-on training tools. The book also provides time-saving information on how to orient employees involved in writing and executing batch manufacturing and in-process control documents. Key Benefits:

• Contains adaptable training text, test summaries and papers, test answers, and certificates of completion
• Streamlines the training process, maximizing efficiency
• Boosts the marketing edge over competitors

This valuable training tool presents step-by-step guidance for optimizing research and development expenditures, avoiding marketing delays, gaining a competitive advantage, reducing product development failures, developing skilled manpower, and maintaining local and international regulatory compliance.

Spis treści

Microbial Growth Text. Culturing Microorganisms. Bioreactor Configurations Text. Bioreactor Design Features Text. Lyophilization: Growing with Biotechnology Text. Shear Effects in Culture Text. Energy Input in Bioreactors Text. Downstream Processing Text. Mammalian Cell Cultures Text. Plant Cell Cultures Text. Fermentation Text. Characteristics of Cells in Culture Text. Cell Lysis Text. Cells Fractionation Text. Centrifugation Text. Homogenization Text. Refolding of Inclusion Bodies Text. Solubilization and Refolding of Proteins Text. Inclusion Bodies Solubilization Text. Sludge Treatment Text. Freeze Drying Text. Vacuum Drying Text. Diafilteration Text. Partition Chromatographs Text. Adsorption Chromatographs Text. Gel Filteration Chromatographs Text. Techniques of Genetic Engineering Text. Industrial Biosafety Text. Certificate of Attainment. Biotechnology Training Records. Recommended Readings. Appendix A ICH Harmonised Tripartite Guideline. Appendix B Guidance for Industry by U.S. Department of Health and Human Services – Food and Drug Administration – Center for Biologics Evaluation and Research (CBER) – February 1999. Appendix C EMEA European Medicine Agency Guideline. Index.

O autorze

Julphar Gulf Pharmaceutical Industries, United Arab Emirates