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Large-Scale Mammalian Cell Culture Technology
An interdisciplinary approach, integrating biochemistry, biology, genetics, and engineering for the effective production of protein pharmaceuticals. The volume offers a biological perspective of large-scale animal cell culture and examines diverse processing strategies, process management, regulator
Characterization of Biotechnology Pharmaceutical Products
This publication addresses the parameters necessary for characterizing the safety, identity, purity, consistency and potency of biotechnology-derived products. The abilities and limitations of current analytical methodologies for defining such products and for assessing their comparability during development are examined. The data reviewed in this volume serve as a foundation for defining the properties of well-characterized products, including proteins and other molecular entities. Discussions span the evaluation of antigenic potential, potency, impurities, DNA/plasmid products, multiantigen peptides, polysaccharides, derivatized proteins, monoclonal antibodies and proteins from natural sources. Finally, recommendations for a consistent approach to the regulation of well-characterized biotechnology products are provided.
Regulatory Practice for Biopharmaceutical Production
Biotechnology represents a novel and expanding international industry bound by new and ever-changing legislature. This text provides a comprehensive overview of product-specific, international and country-specific licensing requirements and general regulatory issues in biotechnology.
Large-Scale Mammalian Cell Culture Technology
An interdisciplinary approach, integrating biochemistry, biology, genetics, and engineering for the effective production of protein pharmaceuticals. The volume offers a biological perspective of large-scale animal cell culture and examines diverse processing strategies, process management, regulator
Process Validation for Manufacturing of Biologics and Biotechnology Products
Attempting to fill the gap Regulatory documents and inspections have put increasing emphasis on process validation for all types of products, including biological and biotechnological ones. Until now, no description of a process validation for complex biological processes exists, let alone any concrete suggestion how to attain it: this book, however, attempts to fill the gap. Taking the current state of scientific practice in process validation as a starting point, this volume portrays the expectations of the regulatory community and provides detailed examples of how various types of biological and biotechnological processes could be validated. Considering the sizeable difficulties in designing a single method of process validation suitable for all types of processes and products, the authors discuss the implications and present many possible routes to a successful validation process.
Process Validation for Manufacturing of Biologics and Biotechnology Products
Attempting to fill the gap Regulatory documents and inspections have put increasing emphasis on process validation for all types of products, including biological and biotechnological ones. Until now, no description of a process validation for complex biological processes exists, let alone any concrete suggestion how to attain it: this book, however, attempts to fill the gap. Taking the current state of scientific practice in process validation as a starting point, this volume portrays the expectations of the regulatory community and provides detailed examples of how various types of biological and biotechnological processes could be validated. Considering the sizeable difficulties in designing a single method of process validation suitable for all types of processes and products, the authors discuss the implications and present many possible routes to a successful validation process.
Genetic Stability and Recombinant Product Consistency
This publication assesses the current state of technology aimed at ensuring the high quality of recombinant-derived biologicals. It will also assist industry and regulatory authorities in their efforts to develop a consensus on the scientific criteria required for the evaluation of genetic stability and product consistency. The papers describe recent progress in methods of nucleic acid sequencing and analytical protein chemistry, as well as strategies for their application. Advances in our understanding of the biology of gene expression are also reviewed. This information is related to data on the development, production and quality control of recombinant biological products. The volume also provides a useful discussion of the value of different approaches.
Viral Safety and Evaluation of Viral Clearance from Biopharmaceutical Products
Assurance that biopharmaceuticals do not contain unwanted infectious agents is a vital safety consideration in the use of these products. This can only be ensured by careful screening of the cells and other materials used in their production, and subsequent testing of the final product. This publication reports the proceedings of an international conference which focused on the methods of how to avoid contamination of cell cultures with virus during the production process of biologicals, with the aim of providing harmonized guidelines to ensure product safety. Scientists from industry and regulatory agencies present updates on the current state of knowledge about assays for viral contamination and procedures for inactivation and removal. Risks associated with the processing of biopharmaceuticals are identified, and data on the actual experiences of testing and industrial laboratories are presented and discussed in the context of the clinical setting. Drawing together a wealth of new data, this book will be essential reading for all scientists concerned with the development, production and quality control of biopharmaceutical products.
Biotransformations and Bioprocesses
From the laboratory to full-scale commercial production, this reference provides a clear and in-depth analysis of bioreactor design and operation and encompasses critical aspects of the biocatalytic manufacturing process. It clarifies principles in reaction and biochemical engineering, synthetic and biotransformation chemistry, and biocell and enzyme kinetics for successful applications of biocatalysis and bioprocess technologies in the food, chiral drug, vitamin, pharmaceutical, and animal feed industries. Studying reactions from small to supramolecules, this reference provides an abundant supply of end-of-chapter problems to sharpen understanding of key concepts presented in the text.
