Biotechnology: A Comprehensive Training Guide for the Biotechnology Industry

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ISBN 9781420084481
Cat# 84488

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Features

  • Provides a training manual for the development, manufacturing, auditing, and validation of biopharmaceuticals
  • Includes a CD-ROM that can be tailored to add changes and in-house training requirements
  • Incorporates both local and international regulatory compliance
  • Offers step-by-step guidance on training new and existing staff on biotechnology concepts

Summary

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.

 

Table of Contents

Microbial Growth Text

Culturing Microorganisms Text

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

Author Bio(s)

Julphar Gulf Pharmaceutical Industries, United Arab Emirates