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Preface | |
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All chapters (except Chapter 12) end with the following sections: Summary, Nomenclature, Problems, and References | |
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Preface | |
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Introduction to Bioproducts and Bioseparations | |
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Instructional Objectives | |
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Broad Classification of Bioproducts | |
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Small Biomolecules | |
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Primary Metabolites | |
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Secondary Metabolites | |
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Summary of Small Biomolecules | |
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Macromolecules: Proteins | |
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Primary Structure | |
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Secondary Structure | |
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Tertiary Structure | |
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Example | |
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Effect of a Reducing Agent on Protein Structure and Mobility | |
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Quaternary Structure | |
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Prosthetic Groups and Hybrid Molecules | |
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Functions and Commercial Uses of Proteins | |
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Stability of Proteins | |
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Recombinant Protein Expression | |
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Macromolecules: Nucleic Acids and Oligonucleotides | |
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Macromolecules: Polysaccharides | |
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Particulate Products | |
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Introduction to Bioseparations: Engineering Analysis | |
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Stages of Downstream Processing | |
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Example | |
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:Initial Selection of Purification Steps | |
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Basic Principles of Engineering Analysis | |
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Process and Product Quality | |
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Criteria for Process Development | |
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The Route to Market | |
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The Chemical and Applications Range of the Bioproduct | |
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Documentation of Pharmaceutical Bioproducts | |
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GLP and cGMP | |
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Formulation | |
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Analytical Methods | |
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Instructional Objectives | |
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Specifications | |
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Assay Attributes | |
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Precision | |
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Accuracy | |
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Specificity | |
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Linearity, Limit of Detection, and Limit of Quantitation | |
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Range | |
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Robustness | |
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Analysis of Biological Activity | |
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Animal Model Assays | |
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Cell-Line-Derived Bioassays | |
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In Vitro Biochemical Assays | |
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Example | |
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:Coupled Enzyme Assay for Alcohol Oxidase | |
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Analysis of Purity | |
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Electrophoretic Analysis | |
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Example | |
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:Estimation of the Maximum Temperature in an Electrophoresis Gel | |
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High Performance Liquid Chromatography (HPLC) | |
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Mass Spectrometry | |
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Coupling of HPLC with Mass Spectrometry | |
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UV Absorbance | |
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Example | |
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:Determination of Molar Absorptivity | |
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CHNO/Amino Acid Analysis (AAA) | |
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Example | |
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:Calculations Based on CHNO Analysis | |
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Protein Assays | |
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Enzyme-Linked Immunosorbent Assay | |
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Gas Chromatography | |
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DNA Hybridization | |
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ICP/MS (AA) | |
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Dry Weight | |
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Microbiology Assays | |
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Sterility | |
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Bioburden | |
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Endotoxin | |
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Virus and Phage | |
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Cell Lysis and Flocculation | |
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Instructional Objectives | |
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Some Elements of Cell Structure | |
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Prokaryotic Cells | |
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Eukaryotic Cells | |
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Cell Lysis | |
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Osmotic and Chemical Cell Lysis | |
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Mechanical Methods of Lysis | |
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Flocculation | |
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The Electric Double Layer | |
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Example | |
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:Dependence of the Debye Radius on the Type of Electrolyte | |
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Forces between Particles and Flocculation by Electrolytes | |
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Example | |
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:Sensitivity of Critical Flocculation Concentration to Temperature and Counter-Ion Charge Number | |
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The Schulze-Hardy Rule | |