Biotechnology: Quality Assurance and Validation provides a practical, detailed discussion of what issues Quality Assurance and Quality Control need to identify for effective control in the preparation of biotechnology products. The book presents a series of topics that define some of the unique challenges facing biotechnology companies in producing biopharmaceutical products. The topics selected address quality and validation issues, starting with the cryopreservation of cell lines through the filling and finishing of the product. It includes a validation guide, a clear presentation of how to use filtration effectively, a synoptic view of cleaning procedures, and much more.

This book covers the principles of cryopreservation as they relate the preservation of viable cells and cell materials being developed for biopharmaceutical applications. Topics include: the principles of freezing and thawing cells, physiochemical phenomena, process and system design options, method selection considerations, preservation procedures, cryoprotectant additives, freeze-drying human live virus vaccines, and transport system selection criteria. Contributions from well-known experts such as Steven S. Lee, Thomas C. Pringle, William H. Siegel, Richard Wisniewski, and Fangdong Yin make this the single most important study available.

This book covers the principles of cryopreservation as they relate the preservation of viable cells and cell materials being developed for biopharmaceutical applications. Topics include: the principles of freezing and thawing cells, physiochemical phenomena, process and system design options, method selection considerations, preservation procedures, cryoprotectant additives, freeze-drying human live virus vaccines, and transport system selection criteria. Contributions from well-known experts such as Steven S. Lee, Thomas C. Pringle, William H. Siegel, Richard Wisniewski, and Fangdong Yin make this the single most important study available.

Biotechnology: Quality Assurance and Validation provides a practical, detailed discussion of what issues Quality Assurance and Quality Control need to identify for effective control in the preparation of biotechnology products. The book presents a series of topics that define some of the unique challenges facing biotechnology companies in producing biopharmaceutical products. The topics selected address quality and validation issues, starting with the cryopreservation of cell lines through the filling and finishing of the product. It includes a validation guide, a clear presentation of how to use filtration effectively, a synoptic view of cleaning procedures, and much more.