Wiley in Biotechnology and Bioengineering

“Quality by Design (QbD)” is a new framework currently being implemented by the FDA, as well as EU and Japanese regulatory agencies, to ensure better understanding of the process so as to yield a consistent and high-quality pharmaceutical product. QbD breaks from past approaches in assuming that drug quality cannot be tested into products; rather, it must be built into every step of the product creation process. “Quality by Design: Perspectives and Case Studies” presents the first systematic approach to QbD in the biotech industry. A comprehensive resource, it combines an in-depth explanation of basic concepts with real-life case studies that illustrate the practical aspects of QbD implementation. In this single source, leading authorities from the biotechnology industry and the FDA discuss such topics as: • The understanding and development of the product's critical quality attributes (CQA) • Development of the design space for a manufacturing process • How to employ QbD to design a formulation process • Raw material analysis and control strategy for QbD • Process Analytical Technology (PAT) and how it relates to QbD • Relevant PAT tools and applications for the pharmaceutical industry • The uses of risk assessment and management in QbD • Filing QbD information in regulatory documents • The application of multivariate data analysis (MVDA) to QbD Filled with vivid case studies that illustrate QbD at work in companies today, “Quality by Design” is a core reference for scientists in the biopharmaceutical industry, regulatory agencies, and students.

Explores current and emerging applications of microbes as cancer-fighting agents. Today, treatment options for cancer patients typically include surgery, radiation therapy, immunotherapy, and chemotherapy. While these therapies have saved lives and reduced pain and suffering, cancer still takes millions of lives every year around the world. In recent years, researchers have been working on a new strategy: developing microbes and microbial products that specifically attack cancer cells. This book breaks new ground in emerging cancer treatment modalities by presenting recent advances in the use of microorganisms and viruses as well as their products in cancer therapy. Seventeen chapters review the application of live microorganisms, high and low molecular weight products derived from microorganisms, and microbial products fused to cancer targeting molecules. In addition, the book highlights the benefits of a multi-target approach to destroy cancer cells. Readers will not only discover the results and significance of basic and clinical research, but also encouraging results from clinical trials. “Emerging Cancer Therapy” is divided into three sections: • Section 1: Live/Attenuated Bacteria and Viruses as Anticancer Agents • Section 2: Bacterial Products as Anticancer Agents • Section 3: Patents on Bacteria/Bacterial Products as Anticancer Agents With chapters written by leading pioneers in microbial, biotech, and cancer research, “Emerging Cancer Therapy” is recommended for biotechnologists, microbiologists, clinical oncologists, medicinal chemists, and biochemists. Readers will not only learn the tremendous potential of microbial and biotechnological approaches to cancer therapy, but also discover new directions of research for effective drug discovery and development.

Sets forth tested and proven risk management practices in drug manufacturing. Risk management is essential for safe and efficient pharmaceutical and biopharmaceutical manufacturing, control, and distribution. With this book as their guide, readers involved in all facets of drug manufacturing have a single, expertly written, and organized resource to guide them through all facets of risk management and analysis. It sets forth a solid foundation in risk management concepts and then explains how these concepts are applied to drug manufacturing. “Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing” features contributions from leading international experts in risk management and drug manufacturing. These contributions reflect the latest research, practices, and industry standards as well as the authors' firsthand experience. Readers can turn to the book for: • Basic foundation of risk management principles, practices, and applications • Tested and proven tools and methods for managing risk in pharmaceutical and biopharmaceutical product manufacturing processes • Recent FDA guidelines, EU regulations, and international standards governing the application of risk management to drug manufacturing • Case studies and detailed examples demonstrating the use and results of applying risk management principles to drug product manufacturing • Bibliography and extensive references leading to the literature and helpful resources in the field With its unique focus on the application of risk management to biopharmaceutical and pharmaceutical manufacturing, this book is an essential resource for pharmaceutical and process engineers as well as safety and compliance professionals involved in drug manufacturing.

“Vaccine Manufacturing and Production” is an invaluable reference on how to produce a vaccine-from beginning to end-addressing all classes of vaccines from a processing, production, and regulatory viewpoint. It will provide comprehensive information on the various fields involved in the production of vaccines, from fermentation, purification, formulation, to regulatory filing and facility designs. In recent years, there have been tremendous advances in all aspects of vaccine manufacturing. Improved technology and growth media have been developed for the production of cell culture with high cell density or fermentation. Vaccine Manufacturing and Production will serve as a reference on all aspects of vaccine production by providing an in-depth description of the available technologies for making different types of vaccines and the current thinking in facility designs and supply issues. This book will provide insight to the issues scientists face when producing a vaccine, the steps that are involved, and will serve as a reference tool regarding state-of-the-art vaccine manufacturing technologies and facility set-up. Highlights include: • Comprehensive coverage of vaccine production: from a process point of view-fermentation to purification to formulation developments; from a production point of view-from facility design to manufacturing; and from a regulatory point of view-requirements from government agencies • Authors from different major pharmaceutical and biotechnology companies • Describes the challenges and issues involved in vaccine production and manufacturing of the different classes of vaccines, an area not covered by other books currently on the market

“Preparative Chromatography for Separation of Proteins” addresses a wide range of modeling, techniques, strategies, and case studies of industrial separation of proteins and peptides. • Covers broad aspects of preparative chromatography with a unique combination of academic and industrial perspectives • Presents Combines modeling with compliance using of Quality-by-Design (QbD) approaches including modeling • Features a variety of chromatographic case studies not readily accessible to the general public • Represents an essential reference resource for academic, industrial, and pharmaceutical researchers

Written for industrial and academic researchers and development scientists in the life sciences industry, Bioprocessing Technology for Production of Biopharmaceuticals and Bioproducts is a guide to the tools, approaches, and useful developments in bioprocessing. This important guide: • Summarizes state-of-the-art bioprocessing methods and reviews applications in life science industries • Includes illustrative case studies that review six milestone bio-products • Discuses a wide selection of host strain types and disruptive bioprocess technologies