Challenging the notion that Nikkei individuals before and during World War II were helpless pawns manipulated by forces beyond their control, the diverse essays in this rich collection focus on the theme of resistance within Japanese American and Japanese Canadian communities to twentieth-century political, cultural, and legal discrimination. They illustrate how Nikkei groups were mobilized to fight discrimination through assertive legal challenges, community participation, skillful print publicity, and political and economic organization. Comprised of all-new and original research, this is the first anthology to highlight the contributions and histories of Nikkei within the entire Pacific Northwest, including British Columbia.
A study of biopharmaceutical process validation. It aims to enable developers and producers to ensure safe products, reduce the risk of adverse reactions in patients, and avoid recalls by outlining sophisticated validation approaches to characterize processes, process intermediates, and final product fully. The text emphasizes cost effectiveness wh
This book will update the original edition published in 1997. Since the publication of the first edition, the biotechnology and biologics industries have gained extensive knowledge and experience in downstream processing using chromatography and other technologies associated with recovery and purification unit operations. This book will tie that experience together for the next generation of readers.Updates include:- sources and productivity- types of products made today- experiences in clinical and licensed products - economics- current status of validation- illustrations and tables- automated column packing- automated systemsNew topics include:- the use of disposables- multiproduct versus dedicated production- design principles for chromatography media and filters- ultrafiltration principles and optimization- risk assessments- characterization studies- design space- platform technologies- process analytical technologies (PATs)- biogenerics - comparability assessmentsKey Features:- new approaches to process optimiaztion- use of patform technologies- applying risk assessment to process design
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