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This book contains both the theory and practice of risk management (RM) and provides the background, tools, and application of risk in pharmaceutical and biologics manufacturing and operations. It includes case studies and specific examples of use of RM for biological and pharmaceutical product manufacture.
Vaccine Production and Manufacturing is a valuable reference on how to produce a vaccine, from beginning to end. It addresses all classes of vaccines from a processing, production, and regulatory viewpoint. It covers everything from fermentation, purification, and formulation to regulatory filing and facility design.
Provides an in-depth understanding of the underlying concepts of Quality by Design (QbD) and the practical aspects of the implementation of QbD in biopharmaceutical manufacturing.
Cancer therapy remains a challenge despite the huge changes and improvements we have made in the scientific and engineering tools that we use. Emerging Cancer Therapy explores the potential and actual uses of live bacteria or their products in the treatment of cancer.
In the wake of rapid advances in genetic technologies, new products continue to be developed to help improve human health and quality of life.
Preparative Chromatography for Separation of Proteins addresses a wide range of the most current modeling techniques, strategies, and case studies of industrial separation of proteins and peptides to aid in the efficiency and efficacy of this broadly-used technique in the purification of biopharmaceuticals.
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