Process Validation in Manufacturing of Biopharmaceuticals: Guidelines, Current Practices, and Industrial Case Studies

Process Validation in Manufacturing of Biopharmaceuticals: Guidelines, Current Practices, and Industrial Case Studies (Hardcover)

By Anurag Singh Rathore , Gail Sofer , Rathore Singh Rathore 
Publisher: Informa Medical
Edition: Hardcover
Edition Number: 2
Language: English
ISBN: 1574445162
EAN: 9781574445169
No. of Units: 1
No. of Pages: 578
Publish Date: 2005-3-1
Binding: Hardcover

Description

Written by top authorities in process validation, this reference explores current trends in the field and strategies for selecting the most appropriate quality control scheme. It offers practical guidelines, recommendations, and an abundance of case studies that showcase various techniques and approaches in the validation of biopharmaceutical processes. These include guidance on determining the life spans of chromatography and filtration media, process characterization and techniques for scaling-down unit operations in biopharmaceutical manufacturing, examples of contamination events, and practical methods for testing raw materials and in-process samples during various manufacturing stages.
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Specification

Title: Process Validation in Manufacturing of Biopharmaceuticals: Guidelines, Current Practices, and Industrial Case Studies
Publisher: Informa Medical
Author: Anurag Singh Rathore , Gail Sofer , Rathore Singh Rathore
Edition: Hardcover
Edition Number: 2
Language: English
ISBN: 1574445162
EAN: 9781574445169
No. of Units: 1
No. of Pages: 578
Publish Date: 2005-3-1
Binding: Hardcover

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