Analysis of aggregates and particles in protein pharmaceuticals /

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...

Πλήρης περιγραφή

Λεπτομέρειες βιβλιογραφικής εγγραφής
Άλλοι συγγραφείς: Mahler, Hanns-Christian, Jiskoot, Wim
Μορφή: Ηλ. βιβλίο
Γλώσσα:English
Έκδοση: Chicester : John Wiley & Sons, 2012.
Θέματα:
Διαθέσιμο Online:Full Text via HEAL-Link
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020 |a 9781118150573  |q (electronic bk.) 
020 |a 1118150570  |q (electronic bk.) 
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049 |a MAIN 
245 0 0 |a Analysis of aggregates and particles in protein pharmaceuticals /  |c edited by Hanns-Christian Mahler, Wim Jiskoot. 
264 1 |a Chicester :  |b John Wiley & Sons,  |c 2012. 
300 |a 1 online resource (474 pages) 
336 |a text  |b txt  |2 rdacontent 
337 |a computer  |b c  |2 rdamedia 
338 |a online resource  |b cr  |2 rdacarrier 
505 0 |a 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. 
505 8 |a 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. 
505 8 |a 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. 
520 |a 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 covered in the book include separation, light scattering, microscopy, and spectroscopy. 
588 0 |a Print version record. 
504 |a Includes bibliographical references. 
650 0 |a Pharmaceutical chemistry. 
650 0 |a Protein drugs  |x Analysis. 
650 4 |a Chemistry Techniques, Analytical  |x methods. 
650 4 |a Pharmaceutical Preparations  |x analysis. 
650 4 |a Proteins  |x pharmacokinetics. 
650 4 |a Pharmacy. 
650 4 |a Medicine. 
655 4 |a Electronic books. 
700 1 |a Mahler, Hanns-Christian. 
700 1 |a Jiskoot, Wim. 
776 0 8 |i Print version:  |a Mahler, Hanns-Christian.  |t Analysis of Aggregates and Particles in Protein Pharmaceuticals.  |d Chicester : John Wiley & Sons, ©2012  |z 9780470497180 
856 4 0 |u https://doi.org/10.1002/9781118150573  |z Full Text via HEAL-Link 
994 |a 92  |b DG1