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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.
In this unique book, experts describe practices applicable to the
large-scale processing of biotechnological products. Beginning with
processing and bulk storage preservation techniques, the book
provides strategies for improving efficiency of process campaigns
of multiple products and manufacturing facilities for such
processing techniques. Large-scale chromatography for the
purification of biomolecules in manufacturing and lyophilization of
protein pharmaceuticals are discussed. Includes a case study on
blow-fill-seal processing technology and a chapter on economic and
cost factors for bioprocess engineering.
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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