Process Validation for Manufacturing of Biologics and Biotechnology Products: Berlin Hilton Hotel, Berlin, Germany, 6 - 7 September, 2001
Fred Brown, Anthony S. Lubiniecki
Karger, 2003 - Medical - 129 pages
Attempting to fill the gap 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.
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An Inspectors Viewpoint
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acceptance criteria activity Amgen analytical animal approach Basel batches biological products biopharmaceutical biotech Biotechnology Biotechnology Products buffer CBER cell bank cell culture cell lines challenge tests characterization chromatography clearance studies clinical trial material column critical parameters cycle detection Dev Biol deviations documented downstream process endogenous retrovirus factor fermentation process filter filtration full-scale Genentech genomic GlaxoSmithKline Herceptin Immunogenicity in-process inactivation infection isoform Karger limits load Lubiniecki manufacturing process methods monitoring monoclonal antibody nanofiltration Note for Guidance Novo Nordisk operating PCR assays Penzberg performed Pharmaceutical potency potential procedures process parameters process steps process validation product quality production cell protein Protein Isoforms protocols purification qualification quantitative PCR raw materials re-processing regulatory resin retrovirus reverse transcriptase Rixensart Roche sample scale scaled-down specific stability standard sterilizing SV40 DNA Total SV40 vaccines validation studies viral clearance viral contaminants virus viruses