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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.
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