Analysis of aggregates and particles in protein pharmaceuticals /

• Άλλοι συγγραφείς: Mahler, Hanns-Christian, Jiskoot, Wim
• Μορφή: Ηλ. βιβλίο
• Γλώσσα: English
• Έκδοση: Chicester : John Wiley & Sons, 2012.
• Θέματα: Pharmaceutical chemistry.; Protein drugs > Analysis.; Chemistry Techniques, Analytical > methods.; Pharmaceutical Preparations > analysis.; Proteins > pharmacokinetics.; Pharmacy.; Medicine.; Electronic books.

This book describes how to address the analysis of aggregates and particles in protein pharmaceuticals, provides a comprehensive overview of current methods and integrated approaches used to quantify and characterize aggregates and particles, and discusses regulatory requirements. Analytical methods...

Πίνακας περιεχομένων:

• ANALYSIS OF AGGREGATES AND PARTICLES IN PROTEIN PHARMACEUTICALS; CONTENTS; Contributors; Preface; Glossary; 1 The Critical Need for Robust Assays for Quantitation and Characterization of Aggregates of Therapeutic Proteins; I METHODS USED FOR DETECTING, QUANTIFYING, AND SIZING OF PROTEIN AGGREGATES AND PARTICLES; 2 Separation-Based Analytical Methods for Measuring Protein Aggregation; 3 Laser Light Scattering-Based Techniques Used for the Characterization of Protein Therapeutics; 4 Online Detection Methods and Emerging Techniques for Soluble Aggregates in Protein Pharmaceuticals.
• 5 Analytical Methods to Measure Subvisible Particulates6 Detection of Visible Particles in Parenteral Products; 7 Characterization of Aggregates and Particles Using Emerging Techniques; II METHODS USED TO CHARACTERIZE PROTEIN AGGREGATES AND PARTICLES; 8 Ultraviolet Absorption Spectroscopy; 9 Fluorescence Spectroscopy to Characterize Protein Aggregates and Particles; 10 Infrared Spectroscopy to Characterize Protein Aggregates; 11 Raman Microscopy for Characterization of Particles; 12 Microscopic Methods for Particle Characterization in Protein Pharmaceuticals.
• III INTEGRATED APPROACHES TO PROTEIN AGGREGATION AND PARTICLES13 Comparison of Methods for Soluble Aggregate Detection and Size Characterization; 14 Protein Purification and Its Relation to Protein Aggregation and Particles; 15 Formulation Development and Its Relation to Protein Aggregation and Particles; Index.