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Quality by Design for Biopharmaceuticals

This is the first book that explains the underlying concepts of Quality by Design (QbD) and the practical aspects of implementing QbD;

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Quality Assurance for Biopharmaceuticals

This volume provides basic guidelines concerning quality assurance and its responsibilities for biopharmaceuticals manufactured by either;

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Biopharmaceutical Production Technology

- Advances in Process Development - Analytical Technologies - Quality Control - Process Design and Management - Changing Face of Processing With;

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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

the strategic importance and value generated by QA/QC for their involvement in control of manufacturing. It will put into perspective the need;

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Biopharmaceuticals

for the production of biologic drugs how manufacturing processes have evolved to meet the global market demand with quality products under the;

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ChitosanBased Systems for Biopharmaceuticals

Chitosan is a linear polysaccharide commercially produced by the deacetylation of chitin. It is non-toxic, biodegradable, biocompatible;

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Preclinical Safety Evaluation of Biopharmaceuticals

The goal is to provide a comprehensive reference book for the preclinicaldiscovery and development scientist whose responsibilities span;

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Process Validation in Manufacturing of Biopharmaceuticals

in the field and strategies for the selection of the most appropriate quality control scheme. It offers practical guidelines, recommendations;

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Detection and Quantification of Antibodies to Biopharmaceuticals

drug development specialists with insight into the design, optimization, and qualification of assays, as well as the establishment of sampling;

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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

is essential, practical information for all pharmaceutical development scientists, Manufacturing and Quality Unit staff, Regulatory Affairs personnel;

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Delivery Technologies for Biopharmaceuticals

stability in the body and limited membrane permeability. Delivery Technologies for Biopharmaceuticals is the first single-volume reference to;

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Pharmaceutical Quality by Design

Pharmaceutical Quality by Design: Principles and Applications discusses the Quality by Design (QbD) concept implemented by regulatory;

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Bioprocessing Technology for Production of Biopharmaceuticals and Bioproducts

In the wake of rapid advances in genetic technologies, new products continue to be developed to help improve human health and quality;

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Glycosylation Engineering of Biopharmaceuticals: Methods and Protocols

characterization, and PK/PD assays for therapeutic antibodies. Written in the highly successful Methods in Molecular Biology (TM) series format, chapters;

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Microspheres and Microcapsules in Biotechnology

, as targeting drug-delivery carriers, separation media for protein, peptide, DNA, and so forth. It is a big challenge to design and prepare;

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Stem Cell Drugs - A New Generation of Biopharmaceuticals

chapter is contributed by a pre-eminent scientist in the field. An introductory section presents current stem cell drugs and stem cell-based;

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Co- and Post-Translational Modifications of Therapeutic Antibodies and Proteins

the ability to design and assess their own structure-function studies for experimental molecules. Specific features and topics include;

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Clinical Trials of Drugs and Biopharmaceuticals

examine how recent advances and increased demand for safer and more effective drugs have changed the process by which drugs are developed and;

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Approaches to the Conformational Analysis of Biopharmaceuticals

, ultraviolet, and Raman spectroscopy. Written by Roger Lundblad, a true pioneer in protein science, this volume supplies the necessary information;

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Approaches to the Conformational Analysis of Biopharmaceuticals

spectroscopy. Written by Roger Lundblad, a true pioneer in protein science, this volume supplies the necessary information researchers need to access;

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SingleUse Technology in Biopharmaceutical Manufacture

dependencies, significant improvements made by suppliers, and the successful application of the single-use technologies Written for;

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Current Applications of Pharmaceutical Biotechnology

therapeutic potential by means of biological and biosimilar medicines, particularly for the treatment of cancer, chronic diseases (e.g. diabetes;

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High-Throughput Formulation Development of Biopharmaceuticals

> The title covers topics such as experiment design, automation of sample preparation and measurements, high-throughput analytics, stress;

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Aseptic Pharmaceutical Manufacturing II

processing to approach the sterility levels achieved with terminal sterilization. Written by experts in sterile manufacturing, this book covers;

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Aseptic Pharmaceutical Manufacturing II

processing to approach the sterility levels achieved with terminal sterilization. Written by experts in sterile manufacturing, this book covers;

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Advances in Pharmaceutical Cell Therapy

all necessary quality measures as a robust and marketable product including an outlook on next generation products and innovative;

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Pharmaceutical Quality by Design

A practical guide to Quality by Design for pharmaceutical product development Pharmaceutical Quality by Design: A Practical Approach;

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