Process validation for manufacturing of biologics and biotechnology products : Berlin Hilton Hotel, Berlin, Germany, 6-7 September, 2001

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書誌事項

Process validation for manufacturing of biologics and biotechnology products : Berlin Hilton Hotel, Berlin, Germany, 6-7 September, 2001

volume editors, Fred Brown, Anthony S. Lubiniecki

（Developments in biologicals, v. 113）

Karger, c2003

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注記

"Proceedings of a symposium co-sponsored by the International Association for Biologicals(IABs) and PDA."

Includes bibliographies and index

内容説明・目次

内容説明

Regulatory documents and inspections have put increasing emphasis on process validation for all types of products, including biological and biotechnological ones. Until now, no description of a process validation for complex biological processes exists, let alone any concrete suggestion how to attain it: this book, however, attempts to fill the gap. Taking the current state of scientific practice in process validation as a starting point, this volume portrays the expectations of the regulatory community and provides detailed examples of how various types of biological and biotechnological processes could be validated. Considering the sizeable difficulties in designing a single method of process validation suitable for all types of processes and products, the authors discuss the implications and present many possible routes to a successful validation process.

目次

  • Expectations for Process Validation: Canadian Perspectives on Expectations for Process Validation, Ridgway, A. Expectations for Process Validation: Industry Perspectives, Francis, R. Strategies: Evolution of Validation Through the Product Life Cycle
  • Statistical Tools for Setting In-Process Acceptance
  • Criteria, Seely, R.J.
  • Munyakazi, L., Haury, J.
  • experience with Validation of Clinical Trial Materials - An Inspector's Viewpoint, Wolfe, L.
  • Upstream Processes: Validation of Fermentation Processes, Lubiniecki, A.S. et al. Strategies: Evolution of Validation Through the Product Life Cycle Site Transfer and Process Validation in Case of Herceptin API, Kuhne, W.
  • Post-Approval Changes: Case Study
  • Detection and Consequences of Recombinant Protein Isoforms - Implications for Biological Potency, Federici, M.M. et al.
  • Physical Methods of Separation: Current Issues in Validation of Chromatography, Sofer, G.
  • Validation of Sterilizing Grade Filtration, Jornitz, M.W., Meltzer, T.H.
  • Viral Clearance: Viruses and Assuring Viral Safety, Robertson, J.S. Viral Clearance and Inactivation Manufacturing Process for Antithrombin III: Concentrate: Viral Validation Studies and Effects of Column Re-Use on Viral Safety, Falbo, A.
  • An Overview of Quantitative PCR Assays for Biologicals: Quality and Safety Evaluation, Xu,Y.
  • Brorson, K.
  • Re-Processing strategies for Biologicals API
  • Manufacturing Processes, Opitz, U.
  • Re-Processing of Biological Products: Regulatory Considerations from the CBER Perspective, Shacter, E.

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