Biophysical Methods for Biotherapeutics Discovery and Development Applications 1st Edition by Tapan K Das ISBN 0470938439 9780470938430

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ISBN 10: 0470938439
ISBN 13: 9780470938430
Author: Tapan K Das

Biophysical Methods for Biotherapeutics Discovery and Development Applications 1st Table of contents:

SECTION 1 EARLY DISCOVERY STAGES AND BIOTHERAPEUTIC CANDIDATE SELECTION
CHAPTER 1 BIOPHYSICAL METHODS APPLIED IN EARLY DISCOVERY OF A BIOTHERAPEUTIC: CASE STUDY OF AN EGFR-IGF1R BISPECIFIC ADNECTIN
1.1 introduction
1.2 target identification
1.3 target generation
1.4 hit evaluation
1.5 lead selection
1.6 lead optimization
1.7 lead formatting
1.8 final development candidate selection
1.9 concluding remarks
acknowledgment
references

CHAPTER 2 X-RAY CRYSTALLOGRAPHY FOR BIOTHERAPEUTICS
2.1 introduction to x-ray crystallography
2.2 modern x-ray crystallography
2.3 x-ray data collection
2.4 solving the structure of the crystal
2.5 understanding the target through structure
2.6 applications of x-ray crystallography to biotherapeutics
2.7 future applications of crystal structures in biotherapeutics
2.8 conclusion
acknowledgments
references

CHAPTER 3 SOLUBILITY AND EARLY ASSESSMENT OF STABILITY FOR PROTEIN THERAPEUTICS
3.1 introduction
3.2 measuring protein solubility
3.3 assessment of protein stability
3.4 computational predictions
3.5 enhance the solubility of biotherapeutics
3.6 development of rapid methods to identify soluble and stable biotherapeutics
3.7 concluding remarks
references

SECTION 2 FIRST-IN-HUMAN AND UP TO PROOF-OF-CONCEPT CLINICAL TRIALS
CHAPTER 4 BIOPHYSICAL AND STRUCTURAL CHARACTERIZATION NEEDED PRIOR TO PROOF OF CONCEPT
4.1 introduction
4.2 biophysical methods for elucidation of protein structure and physiochemical properties
4.3 biophysical and structural characterization data
4.4 case study—characterization of higher order structure of a fusion protein with biophysical methods
4.5 biophysical and structural characterization data in analytical comparability assessments
4.6 summary and future perspectives
acknowledgments
references

CHAPTER 5 NUCLEATION, AGGREGATION, AND CONFORMATIONAL DISTORTION
5.1 introduction
5.2 nonnative aggregation involves multiple competing processes
5.3 importance of conformational changes in forming/nucleating aggregates
5.4 conformational changes during aggregate growth
5.5 surface-mediated unfolding and assembly
5.6 summary
references

CHAPTER 6 UTILIZATION OF CHEMICAL LABELING AND MASS SPECTROMETRY FOR THE BIOPHYSICAL CHARACTERIZATION OF BIOPHARMACEUTICALS
6.1 mass spectrometry of biopharmaceuticals
6.2 introduction to hydrogen/deuterium exchange
6.3 applications of hydrogen/deuterium exchange and mass spectrometry to proteins
6.4 introduction to covalent labeling techniques
6.5 overview and applications of hydroxyl radical footprinting to mass spectrometry
6.6 overview and applications of chemical cross-linking to mass spectrometry
6.7 overview and applications of specific amino acid labeling to mass spectrometry
6.8 conclusions
references

CHAPTER 7 APPLICATION OF BIOPHYSICAL AND HIGH-THROUGHPUT METHODS IN THE PREFORMULATION OF THERAPEUTIC PROTEINS —FACTS AND FICTIONS
7.1 introduction
7.2 considerations for a successful protein drug product
7.3 protein preformulation strategies
7.4 conclusions
references

CHAPTER 8 BIOANALYTICAL METHODS AND IMMUNOGENICITY ASSAYS
8.1 introduction
8.2 assays to assess pk
8.3 biomarker assays
8.4 assays for detection and prediction of anti-drug antibodies
8.5 new trends: biosimilars, biobetters, antibody–drug conjugates
8.6 conclusions
references

CHAPTER 9 STRUCTURES AND DYNAMICS OF PROTEINS PROBED BY UV RESONANCE RAMAN SPECTROSCOPY
9.1 introduction
9.2 experimental
9.3 applications of uvrr spectroscopy to membrane-associated peptides
9.4 protein conformational changes
9.5 challenges and beneffits of uvrr spectroscopy
9.6 conclusion
acknowledgments
references

CHAPTER 10 FREEZING- AND DRYING-INDUCED MICRO- AND NANO-HETEROGENEITY IN BIOLOGICAL SOLUTIONS
10.1 introduction
10.2 freezing-induced heterogeneity
10.3 drying-induced heterogeneity
10.4 methods of detection
10.5 summary
acknowledgments
references

SECTION 3 PHASE III AND COMMERCIAL DEVELOPMENT
CHAPTER 11 LATE-STAGE PRODUCT CHARACTERIZATION: APPLICATIONS IN FORMULATION, PROCESS, AND MANUFACTURING DEVELOPMENT
11.1 introduction
11.2 strategies in using biophysical methods in late-stage development
11.3 analytical methods applications considerations
11.4 concluding remarks
references

CHAPTER 12 BIOPHYSICAL ANALYSES SUITABLE FOR CHEMISTRY, MANUFACTURING, AND CONTROL SECTIONS OF THE BIOLOGIC LICENSE APPLICATION (BLA)
12.1 introduction
12.2 the biophysical tool box
12.3 common biophysical methods for assessing folded structure
12.4 common biophysical methods for assessing size heterogeneity, association state, aggregation
12.5 methods for assessing subvisible particulates
12.6 evolving biophysical technologies
12.7 case study for the use of biophysical methods in the elucidation of structure section of the license application
12.8 case study for the use of biophysical methods in the comparability section of the license application
12.9 case study for the use of biophysical methods in the pharmaceutical development section of the license application
12.10 biophysical methods for evaluating protein—surface/device interaction
12.11 implication for biosimilars
12.12 concluding remarks

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Tags: Tapan K Das, Biophysical Methods, Biotherapeutics Discovery