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

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

Book Details

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

Be the first one to review this product!

Have you used this product?

    

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