(Ebook PDF) Approaches to the Purification Analysis and Characterization of Antibody Based Therapeutics 1st Edition by Allan Mattee ISBN 9780128186572 0128186577 full chapters

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ISBN 10: 0128186577

ISBN 13: 9780128186572

Author: Allan Matte

Approaches to the Purification, Analysis and Characterization of Antibody-Based Therapeutics provides the interested and informed reader with an overview of current approaches, strategies and considerations relating to the purification, analytics and characterization of therapeutic antibodies and related molecules. While there are obviously other books published in and around this subject area, they seem to be either older (c.a. year 2000 publication date) or are more limited in scope. The book will include an extensive bibliography of the published literature in the respective areas covered. It is not, however, intended to be a how-to methods book.

Table of Contents:

Introduction

• 1 – LC-MS characterization of antibody-based therapeutics: recent highlights and future prospects

Section 1 – LC-MS technologies frequently used for the characterization of antibody-based therapeu

• Analysis of intact antibodies
• Middle-up analysis
• Bottom-up analysis
• Higher order structure analysis by mass spectrometry
• Host cell protein analysis

Section 2 – LC-MS characterization of antibody attributes

• Confirmation of primary sequence and detection of cleavages
• Cysteine modifications
• N-linked glycosylation
• O-linked glycosylation
• Glycation
• Deamidation and aspartic acid isomerization
• Oxidation
• Drug conjugates
• Other modifications of antibodies and antibody fusion proteins

Section 3 – Enabling technologies and future directions for LC-MS-based antibody characterization

• New reference materials
• Enabling enzymes
• Top-down and middle-down analysis
• Native mass spectrometry
• Ion mobility mass spectrometry
• Alternative chromatographies for antibody and ADC analysis
• Multi-Attribute Method
• Conclusion
• References
• 2 – Engineering of Protein A for improved purification of antibodies and Fc-fused proteins
• Antibody purification
• Antibody binding proteins
• Staphylococcal Protein A
• Protein A-based purification
• Engineering of Protein A domains for enhanced alkaline stability
• Milder elution conditions in Protein A-based chromatography
• Elution buffer additives for milder elution
• Structural engineering for improved elution
• Loop engineering
• Improving the binding capacity of Protein A resins
• Base matrices and ligand density
• Ligand multimerization
• Optimization of the linker regions
• Ligand coupling
• Summary
• References
• 3 – High fidelity affinity purification of Fc-fusion molecules from product related impurities
• Introduction
• How affinity resins are discovered, developed and manufactured
• Case study 1: Fc-fusion protein #1
• Case study 2: Fc-fusion protein #2
• Case study 3: A general approach to purification of bispecific antibodies
• Case study 4: heterodimer specific resins
• Summary
• References
• 4 – Recent advances in continuous downstream processing of antibodies and related products
• Introduction
• Introduction: drivers for change in biopharm manufacturing – changing landscape
• Biosimilars
• Multiple mAbs for the same indication
• Intensified upstream process and the downstream bottleneck
• Small molecule success and regulatory drive
• Pros and cons of continuous processing
• Key enabling technologies for continuous processing
• Acoustic wave separation
• Multicolumn chromatography
• Low pH virus inactivation
• Continuous stirred tank reactors
• Cyclical flow reactors
• Column based strategies
• Alternatives to low pH virus inactivation
• Single-pass tangential flow filtration
• Single-pass tangential flow filtration (SPTFF)
• SPTFF for in line diafiltration (ILDF)
• Updates from early adopters
• Alvotech
• Amgen
• BiosanaPharma
• Boehringer ingelheim (BI) and pfizer
• Enzene
• Genzyme
• Just Biotherapeutics
• Merck
• Novartis
• Conclusion: tipping point
• References
• 5 – Recent advances in antibody-based monolith chromatography for therapeutic applications
• Introduction
• State of the art of antibody-based monolith chromatography
• Generalities and fundamentals
• Advantages and limitations
• Recent advances in purification of antibodies
• Recent advances in immobilization of antibodies
• Therapeutic applications
• Diagnosis and analysis
• Treatment
• Future trends and concluding remarks
• References
• 6 – Recent advances in harvest clarification for antibodies and related products
• Introduction
• Advances in mechanical separation methods
• Encapsulated depth filters
• Non-woven depth filters
• Synthetic depth filters
• Body feed
• Pretreatment technologies
• Cell retention devices
• Analytical technologies for clarification
• References
• 7 – Recent advances in ultrafiltration and virus filtration for production of antibodies and related
• Introduction
• Virus filtration
• Introduction
• Recent regulatory trends
• Virus filter classification and use
• Modular virus clearance validation
• Quality by design
• Virus filter clearance validation using only small viruses
• Relevant process trends
• Increased mAb concentration
• Connected and continuous processing
• Virus clearance validation for connected and continuous processes
• Process pauses
• Filtration as an upstream viral barrier
• Filtration technology development
• Membranes and filtration devices
• Adsorptive prefiltration
• Virus retention mechanisms
• Ultrafiltration
• High concentration formulation
• High solution viscosity
• Low final batch volume
• Excipient offsets
• Single-pass tangential flow filtration
• Single-pass TFF operation
• Applications for single-pass TFF
• SPTFF system considerations
• Single-use tangential flow filtration
• References
• 8 – A roadmap for IgG-like bispecific antibody purification
• Introduction
• Asymmetric bsAb
• Homodimer
• bsAb constructed using the KiH technology
• bsAb with electrostatic interaction driven heterodimerization
• bsAb based on WuXiBody platform
• bsAb with pI engineered HC
• bsAb with Protein A-binding abolished HC
• Common HC bsAb – κλ-body
• Single-chain variable fragment (scFv)-Fc
• Half antibody
• Symmetric bsAb
• Protein A chromatography
• Hydrophobic interaction chromatography (HIC)
• Capto MMC ImpRes and Capto adhere chromatographies
• HA chromatography
• CEX chromatography
• Purification roadmap
• Concluding remarks
• Acknowledgment
• References
• 9 – High-throughput, parallelized and automated protein purification for therapeutic antibody develo
• Introduction
• Small-scale equipment and strategies
• Liquid handling platforms
• Resin-filled purification tips
• Magnetic beads
• Plate-based membrane chemistries
• Batch purification in plates
• Robo columns
• Buffer exchange and protein concentration
• Mid-scale purification strategies
• Batch methods
• Automation options
• Protein Maker
• Modified FPLC and HPLC systems
• Magnetic resin based separations
• Membrane-based and monolith devices
• Applications to HT process development
• Non-chromatographic HT purification approaches
• Batch crystallization
• Precipitation
• Aqueous two-phase systems
• Summary and conclusions
• References

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Purification,Analysis,Characterization,Antibody Based Therapeutics,Allan Mattee