[PDF] Therapeutic Monoclonal Antibodies And Antibody Products Their Optimization And Drug Design In Cancers eBook
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The book broadly deals with therapeutic monoclonal antibodies (mAbs) and various relevant topics, including different antibody formats such as Antibody-Drug Conjugates (ADC), bispecifics, nanoparticle-based mAbs and HER2+ cancers, immune checkpoint inhibitors and other closely related topics. Each paper was written by leading active research groups in their fields both from academia and industry. The book should be of interest to those scientists and researchers who develop or use biologics, biotherapeutics, biosimilars and biobetters in cancer treatment.
Antibody-drug conjugates (ADCs) stand at the verge of a transformation. Scores of clinical programs have yielded only a few regulatory approvals, but a wave of technological innovation now empowers us to overcome past technical challenges. This volume focuses on the next generation of ADCs and the innovations that will enable them. The book inspires the future by integrating the field’s history with novel strategies and cutting-edge technologies. While the book primarily addresses ADCs for solid tumors, the last chapter explores the emerging interest in using ADCs to treat other diseases. The therapeutic rationale of ADCs is strong: to direct small molecules to the desired site of action (and away from normal tissues) by conjugation to antibodies or other targeting moieties. However, the combination of small and large molecules imposes deep complexity to lead optimization, pharmacokinetics, toxicology, analytics and manufacturing. The field has made significant advances in all of these areas by improving target selection, ADC design, manufacturing methods and clinical strategies. These innovations will inspire and educate scientists who are designing next-generation ADCs with the potential to transform the lives of patients.
70-chapter authoritative reference that covers therapeutic monoclonal antibody discovery, development, and clinical applications while incorporating principles, experimental data, and methodologies. First book to address the discovery and development of antibody therapeutics in their entirety. Most chapters contain experimental data to illustrate the principles described in them. Authors provide detailed methodologies that readers can take away with them and use in their own laboratories.
This volume gathers the leading research on antibody-drug conjugates and immunotoxins. Following a rigorous overview, the volume delves into focused sections on all aspects of ADCs and ITs from clinical development through to targeted therapeutic applications and the latest technologies.
Therapeutic Monoclonal Antibodies: From Lot Release to Stability Testing is a highly topical resource on a subject of interest for scientists and researchers working on monoclonal antibodies' characterization, release testing, stability testing and similarity assessments of monoclonal antibodies in the biopharmaceutical industry. Monoclonal antibodies (mAbs) are large, extremely complex and dynamic biomolecules, so it can be challenging to develop well-characterized therapeutic antibodies that meet regulatory expectations that are also in-line with commercialized standards for different drug markets. Lot release testing and understanding the stability of the mAb over a period of time, and in different environmental conditions, is an indispensable aspect of mAb physicochemical characterization. This book covers the process, including extensive analysis that starts with quantifying the purity attribute to glycan profiling and identifying the mAb primary structure. The book has a primary purpose of focusing on both Lot release testing and stability testing of monoclonal antibodies (subjects not covered in any great detail in other books). Discusses, in detail, the Lot release methods for both drug substance and drug product, along with their importance in process sample analysis Gives specific attention to general characteristics tests, such as pH determination, osmolality, sub-visible particle count, appearance and visible tests, and regulatory/pharmacopeial guidelines Includes different kinds of stability testing (real time, accelerated and stressed) and their importance and determinations on product shelf life Presents regulatory guidelines on ICH Q2R1, ICHQ6B and ICHQ5C, which are discussed along with analytical method validation, monoclonal antibodies physicochemical characterization and stability testing Provides different characterization methods and validation and development case studies of monoclonal antibodies, including biosimilars and innovators
KENNETH A. FOON and ALTON C. MORGAN, JR. Passive immunotherapy using heteroantisera for the treatment of cancer in animals and humans has been studied for over 50 years. Attempts have been made to treat animal tumors with sera from immunized syngeneic, allogeneic, or xenogeneic animals. A number of studies of passive immunotherapy using heterologous antisera in humans have also been performed. These studies have generally been attempted in patients with large tumor burdens, and as would be expected, results have been transient at best. A wide variety of solid tumors as well as leukemias and lym phomas have been treated with antisera raised in sheep, horses, rabbits, and goats. Problems such as anaphylaxis, serum sick ness, and severe cytopenias have been encountered with these antisera. There are a number of potential mechanisms by which unconju gated antibodies might be cytotoxic to tumor cells. Antibodies bound to the cell surface membrane of tumor cells may lead to cell lysis by complement-dependent or antibody-dependent cellu lar cytotoxicity. Circulating tumor cells bound by antibody may be more susceptible to phagocytosis by the reticuloendothelial system. Antibody bound to the cell surface membrane of tumor cells may enhance immunogenicity of the tumor cell leading to activation of the host's immune system.
A review of therapeutic antibodies which have commercial potential. It discusses PCR cloning of Igs, immortalization by gene transfer, scale up production, infectious diseases, viruses, bacteria, parisites, inflammation/immunology, blood grouping, cells, cytokines, tumours and MDR.
With a key focus on recent developments and advances in the field, this book provides in-depth coverage of topics fundamental to the development of targeted therapeutics. The expansion of targeted modalities in rapidly evolving therapeutic areas, such as immune-oncology, and developments with respect to combination therapies, novel technologies, and the therapeutic application of antibody-drug conjugates, are presented. Additionally, the book builds upon topics discussed in the first edition (2012) where recent innovations warrant elaboration. This, the second edition of Development of Antibody-Based Therapeutics: Translational Considerations, represents a comprehensive evaluation of progress in the field, which sits alongside the first edition to inform, in detail, professional and academic researchers, as well as graduate students.
Antibody-drug conjugates (ADCs) represent a promising therapeutic approach for cancer patients by combining the antigen-targeting specificity of monoclonal antibodies (mAbs) with the cytotoxic potency of chemotherapeutic drugs. In Antibody-Drug Conjugates, expert researchers provide detailed protocols for many of the key ADC techniques necessary for working in the field. These chapters and methodologies are aimed at the key tasks necessary to identify a suitable target, properly design the mAb, the linker and the payload, as well as to conjugate them in a reproducible and scalable fashion. Written in the highly successful Methods in Molecular BiologyTM format, these detailed chapters include the kind of practical implementation advice that guarantees quality results. Authoritative and timely, Antibody-Drug Conjugates aims to further drive ADC development and thus help toward improving cancer treatments of the future.