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| developability assessment of therapeutic antibodies: Developability of Biotherapeutics Sandeep Kumar, Satish Kumar Singh, 2015-11-18 Biopharmaceuticals are emerging as frontline medicines to combat several life-threatening and chronic diseases. However, such medicines are expensive to develop and produce on a commercial scale, contributing to rising healthcare costs. Developability of Biotherapeutics: Computational Approaches describes applications of computational and molecular |
| developability assessment of therapeutic antibodies: State-Of-the-Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization Volume 2. Biopharmaceutical Characterization John E. Schiel, Darryl L. Davis, Oleg V. Borisov, Oleg Borisov, 2016-06-24 Distributed in print by Oxford University Press. |
| developability assessment of therapeutic antibodies: Therapeutic Antibody Engineering William R Strohl, Lila M Strohl, 2012-10-16 The field of antibody engineering has become a vital and integral part of making new, improved next generation therapeutic monoclonal antibodies, of which there are currently more than 300 in clinical trials across several therapeutic areas. Therapeutic antibody engineering examines all aspects of engineering monoclonal antibodies and analyses the effect that various genetic engineering approaches will have on future candidates. Chapters in the first part of the book provide an introduction to monoclonal antibodies, their discovery and development and the fundamental technologies used in their production. Following chapters cover a number of specific issues relating to different aspects of antibody engineering, including variable chain engineering, targets and mechanisms of action, classes of antibody and the use of antibody fragments, among many other topics. The last part of the book examines development issues, the interaction of human IgGs with non-human systems, and cell line development, before a conclusion looking at future issues affecting the field of therapeutic antibody engineering. - Goes beyond the standard engineering issues covered by most books and delves into structure-function relationships - Integration of knowledge across all areas of antibody engineering, development, and marketing - Discusses how current and future genetic engineering of cell lines will pave the way for much higher productivity |
| developability assessment of therapeutic antibodies: Analytical Characterization of Biotherapeutics Jennie R. Lill, Wendy Sandoval, 2017-08-14 The definitive guide to the myriad analytical techniques available to scientists involved in biotherapeutics research Analytical Characterization of Biotherapeutics covers all current and emerging analytical tools and techniques used for the characterization of therapeutic proteins and antigen reagents. From basic recombinant antigen and antibody characterization, to complex analyses for increasingly complex molecular designs, the book explores the history of the analysis techniques and offers valuable insights into the most important emerging analytical solutions. In addition, it frames critical questions warranting attention in the design and delivery of a therapeutic protein, exposes analytical challenges that may occur when characterizing these molecules, and presents a number of tested solutions. The first single-volume guide of its kind, Analytical Characterization of Biotherapeutics brings together contributions from scientists at the leading edge of biotherapeutics research and manufacturing. Key topics covered in-depth include the structural characterization of recombinant proteins and antibodies, antibody de novo sequencing, characterization of antibody drug conjugates, characterization of bi-specific or other hybrid molecules, characterization of manufacturing host-cell contaminant proteins, analytical tools for biologics molecular assessment, and more. Each chapter is written by a recognized expert or experts in their field who discuss current and cutting edge approaches to fully characterizing biotherapeutic proteins and antigen reagents Covers the full range of characterization strategies for large molecule based therapeutics Provides an up-to-date account of the latest approaches used for large molecule characterization Chapters cover the background needed to understand the challenges at hand, solutions to characterize these large molecules, and a summary of emerging options for analytical characterization Analytical Characterization of Biotherapeutics is an up-to-date resource for analytical scientists, biologists, and mass spectrometrists involved in the analysis of biomolecules, as well as scientists employed in the pharmaceuticals and biotechnology industries. Graduate students in biology and analytical science, and their instructors will find it to be fascinating and instructive supplementary reading. |
| developability assessment of therapeutic antibodies: Protein Engineering Huimin Zhao, 2021-08-23 A one-stop reference that reviews protein design strategies to applications in industrial and medical biotechnology Protein Engineering: Tools and Applications is a comprehensive resource that offers a systematic and comprehensive review of the most recent advances in the field, and contains detailed information on the methodologies and strategies behind these approaches. The authors—noted experts on the topic—explore the distinctive advantages and disadvantages of the presented methodologies and strategies in a targeted and focused manner that allows for the adaptation and implementation of the strategies for new applications. The book contains information on the directed evolution, rational design, and semi-rational design of proteins and offers a review of the most recent applications in industrial and medical biotechnology. This important book: Covers technologies and methodologies used in protein engineering Includes the strategies behind the approaches, designed to help with the adaptation and implementation of these strategies for new applications Offers a comprehensive and thorough treatment of protein engineering from primary strategies to applications in industrial and medical biotechnology Presents cutting edge advances in the continuously evolving field of protein engineering Written for students and professionals of bioengineering, biotechnology, biochemistry, Protein Engineering: Tools and Applications offers an essential resource to the design strategies in protein engineering and reviews recent applications. |
| developability assessment of therapeutic antibodies: Development of Biopharmaceutical Drug-Device Products Feroz Jameel, John W. Skoug, Robert R. Nesbitt, 2020-03-13 The biotechnology/biopharmaceutical sector has tremendously grown which led to the invention of engineered antibodies such as Antibody Drug Conjugates (ADCs), Bispecific T-cell engager (BITES), Dual Variable Domain (DVD) antibodies, and fusion proteins that are currently being used as therapeutic agents for immunology, oncology and other disease conditions. Regulatory agencies have raised the bar for the development and manufacture of antibody-based products, expecting to see the use of Quality by Design (QbD) elements demonstrating an in-depth understanding of product and process based on sound science. Drug delivery systems have become an increasingly important part of the therapy and most biopharmaceuticals for self-administration are being marketed as combination products. A survey of the market indicates that there is a strong need for a new book that will provide “one stop shopping” for the latest information and knowledge of the scientific and engineering advances made over the last few years in the area of biopharmaceutical product development. The new book entitled Development of Biopharmaceutical Drug Device Products is a reference text for scientists and engineers in the biopharmaceutical industry, academia or regulatory agencies. With insightful chapters from experts in the field, this new book reviews first principles, covers recent technological advancements and provides case studies and regulatory strategies relating to the development and manufacture of antibody-based products. It covers topics such as the importance of early preformulation studies during drug discovery to influence molecular selection for development, formulation strategies for new modalities, and the analytical techniques used to characterize them. It also addresses important considerations for later stage development such as the development of robust formulations and processes, including process engineering and modeling of manufacturing unit operations, the design of analytical comparability studies, and characterization of primary containers (pre-filled syringes and vials).Finally, the latter half of the book reviews key considerations to ensure the development and approval of a patient-centered delivery system design. This involves the evolving regulatory framework with perspectives from both the US and EU industry experts, the role of international standards, design control/risk management, human factors and its importance in the product development and regulatory approval process, as well as review of the risk-based approach to bridging between devices used in clinical trials and the to-be-marketed device. Finally, case studies are provided throughout.The typical readership would have biology and/or engineering degrees and would include researchers, scientific leaders, industry specialists and technology developers working in the biopharmaceutical field. |
| developability assessment of therapeutic antibodies: Antibody Drug Discovery Clive R. Wood, 2012 Antibody-based therapeutics are a central driver of the success of biopharmaceuticals. The discovery technology of this field is isolated to a limited number of centers of excellence in industry and academia. The objective of this volume is to provide a series of guides to those evaluating and preparing to enter particular areas within the field. Each chapter is written with a historical perspective that sets into context the significance of the key developments, and with the provision of “points to consider” for the reader as a value-added feature of the volume. All contributors are experts in their fields and have played pivotal roles in the creation of the technology. |
| developability assessment of therapeutic antibodies: Aggregation of Therapeutic Proteins Wei Wang, Christopher J. Roberts, 2010-12-28 This book gives pharmaceutical scientists an up-to-date resource on protein aggregation and its consequences, and available methods to control or slow down the aggregation process. While significant progress has been made in the past decade, the current understanding of protein aggregation and its consequences is still immature. Prevention or even moderate inhibition of protein aggregation has been mostly experimental. The knowledge in this book can greatly help pharmaceutical scientists in the development of therapeutic proteins, and also instigate further scientific investigations in this area. This book fills such a need by providing an overview on the causes, consequences, characterization, and control of the aggregation of therapeutic proteins. |
| developability assessment of therapeutic antibodies: Innovations for Next-Generation Antibody-Drug Conjugates Marc Damelin, 2018-05-29 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. |
| developability assessment of therapeutic antibodies: Fc Receptors Marc Daeron, Falk Nimmerjahn, 2014-08-12 This volume provides a state-of-the-art update on Fc Receptors (FcRs). It is divided into five parts. Part I, Old and New FcRs, deals with the long-sought-after FcμR and the recently discovered FCRL family and TRIM21. Part II, FcR Signaling, presents a computational model of FcεRI signaling, novel calcium channels, and the lipid phosphatase SHIP1. Part III, FcR Biology, addresses major physiological functions of FcRs, their glycosylation, how they induce and regulate both adaptive immune responses and inflammation, especially in vivo, FcR humanized mice, and the multifaceted properties of FcRn. Part IV, FcRs and Disease, discusses FcR polymorphism, FcRs in rheumatoid arthritis and whether their FcRs make macaques good models for studying HIV infection. In Part V, FcRs and Therapeutic Antibodies, the roles of various FcRs, including FcγRIIB and FcαRI, in the immunotherapy of cancer and autoimmune diseases using monoclonal antibodies and IVIg are highlighted. All 18 chapters were written by respected experts in their fields, offering an invaluable reference source for scientists and clinicians interested in FcRs and how to better master antibodies for therapeutic purposes. |
| developability assessment of therapeutic antibodies: Fusion Protein Technologies for Biopharmaceuticals Stefan R. Schmidt, 2013-01-28 The state of the art in biopharmaceutical FUSION PROTEIN DESIGN Fusion proteins belong to the most lucrative biotech drugs—with Enbrel® being one of the best-selling biologics worldwide. Enbrel® represents a milestone of modern therapies just as Humulin®, the first therapeutic recombinant protein for human use, approved by the FDA in 1982 and Orthoclone® the first monoclonal antibody reaching the market in 1986. These first generation molecules were soon followed by a plethora of recombinant copies of natural human proteins, and in 1998, the first de novo designed fusion protein was launched. Fusion Protein Technologies for Biopharmaceuticals examines the state of the art in developing fusion proteins for biopharmaceuticals, shedding light on the immense potential inherent in fusion protein design and functionality. A wide pantheon of international scientists and researchers deliver a comprehensive and complete overview of therapeutic fusion proteins, combining the success stories of marketed drugs with the dynamic preclinical and clinical research into novel drugs designed for as yet unmet medical needs. The book covers the major types of fusion proteins—receptor-traps, immunotoxins, Fc-fusions and peptibodies—while also detailing the approaches for developing, delivering, and improving the stability of fusion proteins. The main body of the book contains three large sections that address issues key to this specialty: strategies for extending the plasma half life, the design of toxic proteins, and utilizing fusion proteins for ultra specific targeting. The book concludes with novel concepts in this field, including examples of highly relevant multifunctional antibodies. Detailing the innovative science, commercial realities, and brilliant potential of fusion protein therapeutics, Fusion Protein Technologies for Biopharmaceuticals is a must for pharmaceutical scientists, biochemists, medicinal chemists, molecular biologists, pharmacologists, and genetic engineers interested in determining the shape of innovation in the world of biopharmaceuticals. |
| developability assessment of therapeutic antibodies: Immunoinformatics Christian Schönbach, Shoba Ranganathan, Vladimir Brusic, 2007-11-21 In contrast to existing books on immunoinformatics, this volume presents a cross-section of immunoinformatics research. The contributions highlight the interdisciplinary nature of the field and how collaborative efforts among bioinformaticians and bench scientists result in innovative strategies for understanding the immune system. Immunoinformatics is ideal for scientists and students in immunology, bioinformatics, microbiology, and many other disciplines. |
| developability assessment of therapeutic antibodies: Biophysical Characterization of Proteins in Developing Biopharmaceuticals Damian J. Houde, Steven A. Berkowitz, 2019-11-13 Biophysical Characterization of Proteins in Developing Biopharmaceuticals, Second Edition, presents the latest on the analysis and characterization of the higher-order structure (HOS) or conformation of protein based drugs. Starting from the very basics of protein structure, this book explains the best way to achieve this goal using key methods commonly employed in the biopharmaceutical industry. This book will help today's industrial scientists plan a career in this industry and successfully implement these biophysical methodologies. This updated edition has been fully revised, with new chapters focusing on the use of chromatography and electrophoresis and the biophysical characterization of very large biopharmaceuticals. In addition, best practices of applying statistical analysis to biophysical characterization data is included, along with practical issues associated with the concept of a biopharmaceutical's developability and the technical decision-making process needed when dealing with biophysical characterization data. - Presents basic protein characterization methods and tools applicable to (bio)pharmaceutical research and development - Highlights the capabilities and limitations of each technique - Discusses the underlining science of each tool - Empowers industrial biophysical chemists by providing a roadmap for applying biophysical tools - Outlines the needs for new characterization and analytical tools in the biopharmaceutical industry |
| developability assessment of therapeutic antibodies: Development of Antibody-Based Therapeutics Mohammad A. Tabrizi, Gadi G. Bornstein, Scott L. Klakamp, 2018-09-11 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. |
| developability assessment of therapeutic antibodies: Immunogenicity of Proteins Used as Therapeutics Amy Rosenberg, Zuben E. Sauna, Bernard Maillere, Susan Richards, Elizabeth C. Jury, 2020-12-28 Topic Editor Susan Richards is an employee of Sanofi and owns stock in the corporation. Topic Editor Bernard Maillere declares economic support from pharmaceutical companies (Novartis, Sanofi, and UCB) in the frame of collaborations aiming to evaluate the recognition by human T cells of therapeutic proteins and antibodies. |
| developability assessment of therapeutic antibodies: Monoclonal Antibody Production National Research Council, Institute for Laboratory Animal Research, Committee on Methods of Producing Monoclonal Antibodies, 1999-05-06 The American Anti-Vivisection Society (AAVS) petitioned the National Institutes of Health (NIH) on April 23, 1997, to prohibit the use of animals in the production of mAb. On September 18, 1997, NIH declined to prohibit the use of mice in mAb production, stating that the ascites method of mAb production is scientifically appropriate for some research projects and cannot be replaced. On March 26, 1998, AAVS submitted a second petition, stating that NIH failed to provide valid scientific reasons for not supporting a proposed ban. The office of the NIH director asked the National Research Council to conduct a study of methods of producing mAb. In response to that request, the Research Council appointed the Committee on Methods of Producing Monoclonal Antibodies, to act on behalf of the Institute for Laboratory Animal Research of the Commission on Life Sciences, to conduct the study. The 11 expert members of the committee had extensive experience in biomedical research, laboratory animal medicine, animal welfare, pain research, and patient advocacy (Appendix B). The committee was asked to determine whether there was a scientific necessity for the mouse ascites method; if so, whether the method caused pain or distress; and, if so, what could be done to minimize the pain or distress. The committee was also asked to comment on available in vitro methods; to suggest what acceptable scientific rationale, if any, there was for using the mouse ascites method; and to identify regulatory requirements for the continued use of the mouse ascites method. The committee held an open data-gathering meeting during which its members summarized data bearing on those questions. A 1-day workshop (Appendix A) was attended by 34 participants, 14 of whom made formal presentations. A second meeting was held to finalize the report. The present report was written on the basis of information in the literature and information presented at the meeting and the workshop. |
| developability assessment of therapeutic antibodies: Innovative Dosage Forms Yogeshwar Bachhav, 2019-12-04 Teaches future and current drug developers the latest innovations in drug formulation design and optimization This highly accessible, practice-oriented book examines current approaches in the development of drug formulations for preclinical and clinical studies, including the use of functional excipients to enhance solubility and stability. It covers oral, intravenous, topical, and parenteral administration routes. The book also discusses safety aspects of drugs and excipients, as well as regulatory issues relevant to formulation. Innovative Dosage Forms: Design and Development at Early Stage starts with a look at the impact of the polymorphic form of drugs on the preformulation and formulation development. It then offers readers reliable strategies for the formulation development of poorly soluble drugs. The book also studies the role of reactive impurities from the excipients on the formulation shelf life; preclinical formulation assessment of new chemical entities; and regulatory aspects for formulation design. Other chapters cover innovative formulations for special indications, including oncology injectables, delayed release and depot formulations; accessing pharmacokinetics of various dosage forms; physical characterization techniques to assess amorphous nature; novel formulations for protein oral dosage; and more. -Provides information that is essential for the drug development effort -Presents the latest advances in the field and describes in detail innovative formulations, such as nanosuspensions, micelles, and cocrystals -Describes current approaches in early pre-formulation to achieve the best in vivo results -Addresses regulatory and safety aspects, which are key considerations for pharmaceutical companies -Includes case studies from recent drug development programs to illustrate the practical challenges of preformulation design Innovative Dosage Forms: Design and Development at Early Stage provides valuable benefits to interdisciplinary drug discovery teams working in industry and academia and will appeal to medicinal chemists, pharmaceutical chemists, and pharmacologists. |
| developability assessment of therapeutic antibodies: Industrial Scale Suspension Culture of Living Cells Hans-Peter Meyer, Diego Schmidhalter, 2014-08-04 The submersed cultivation of organisms in sterile containments or fermenters has become the standard manufacturing procedure, and will remain the gold standard for some time to come. This book thus addresses submersed cell culture and fermentation and its importance for the manufacturing industry. It goes beyond expression systems and integrally investigates all those factors relevant for manufacturing using suspension cultures. In so doing, the contributions cover all industrial cultivation methods in a comprehensive and comparative manner, with most of the authors coming from the industry itself. Depending on the maturity of the technology, the chapters address in turn the expression system, basic process design, key factors affecting process economics, plant and bioreactor design, and regulatory aspects. |
| developability assessment of therapeutic antibodies: Protein Therapeutics, 2 Volume Set Tristan Vaughan, Jane Osbourn, Bahija Jallal, 2017-12-04 Branchenführende Big-Pharma-Unternehmen und erstklassige Forscher präsentieren grundlegende Konzepte und Herausforderungen bei proteinbasierten Pharmazeutika. Beinhaltet auch eine Einführung in die aus Sicht der Arzneimittelentwicklung fünf wesentlichen Anwendungsbereiche. |
| developability assessment of therapeutic antibodies: Antibody Glycosylation Marija Pezer, 2021-10-22 This book summarizes recent advances in antibody glycosylation research. Covering major topics relevant for immunoglobulin glycosylation - analytical methods, biosynthesis and regulation, modulation of effector functions - it provides new perspectives for research and development in the field of therapeutic antibodies, biomarkers, vaccinations, and immunotherapy. Glycans attached to both variable and constant regions of antibodies are known to affect the antibody conformation, stability, and effector functions. Although it focuses on immunoglobulin G (IgG), the most explored antibody in this context, and unravels the natural phenomena resulting from the mixture of IgG glycovariants present in the human body, the book also discusses other classes of human immunoglobulins, as well as immunoglobulins produced in other species and production systems. Further, it reviews the glycoanalytical methods applied to antibodies and addresses a range of less commonly explored topics, such as automatization and bioinformatics aspects of high-throughput antibody glycosylation analysis. Lastly, the book highlights application areas ranging from the ones already benefitting from antibody glycoengineering (such as monoclonal antibody production), to those still in the research stages (such as exploration of antibody glycosylation as a clinical or biological age biomarker), and the potential use of antibody glycosylation in the optimization of vaccine production and immunization protocols. Summarizing the current knowledge on the broad topic of antibody glycosylation and its therapeutic and biomarker potential, this book will appeal to a wide biomedical readership in academia and industry alike. Chapter 4 is available open access under a Creative Commons Attribution 4.0 International License via link.springer.com. |
| developability assessment of therapeutic antibodies: Monoclonal Antibody-Directed Therapy Veysel Kayser, Amita Datta-Mannan, 2022-01-28 The book deals with therapeutic monoclonal antibodies (mAbs) broadly, and relevant topics such as challenges and opportunities, next-generation antibody products, Antibody-Drug-Conjugates (ADC), bispecifics, glycosylation, and T-cell engagers are covered. Each topic has been written by leading groups around the world and the book should be of interest to researchers from both academia and industry. |
| developability assessment of therapeutic antibodies: Antibody Fc Margaret Ackerman, Falk Nimmerjahn, 2013-08-06 Antibody Fc is the first single text to synthesize the literature on the mechanisms underlying the dramatic variability of antibodies to influence the immune response. The book demonstrates the importance of the Fc domain, including protective mechanisms, effector cell types, genetic data, and variability in Fc domain function. This volume is a critical single-source reference for researchers in vaccine discovery, immunologists, microbiologists, oncologists and protein engineers as well as graduate students in immunology and vaccinology. Antibodies represent the correlate of protection for numerous vaccines and are the most rapidly growing class of drugs, with applications ranging from cancer and infectious disease to autoimmunity. Researchers have long understood the variable domain of antibodies, which are responsible for antigen recognition, and can provide protection by blocking the function of their target antigen. However, recent developments in our understanding of the protection mediated by antibodies have highlighted the critical nature of the antibody constant, or Fc domain, in the biological activity of antibodies. The Fc domain allows antibodies to link the adaptive and innate immune systems, providing specificity to a wide range of innate effector cells. In addition, they provide a feedback loop to regulate the character of the immune response via interactions with B cells and antigen-presenting cells. - Clarifies the different mechanisms of IgG activity at the level of the different model systems used, including human genetic, mouse, and in vitro - Covers the role of antibodies in cancer, infectious disease, and autoimmunity and in the setting of monoclonal antibody therapy as well as naturally raised antibodies - Color illustrations enhance explanations of the immune system |
| developability assessment of therapeutic antibodies: Process Scale Purification of Antibodies Uwe Gottschalk, 2017-03-07 Promoting a continued and much-needed renaissance in biopharmaceutical manufacturing, this book covers the different strategies and assembles top-tier technology experts to address the challenges of antibody purification. • Updates existing topics and adds new ones that include purification of antibodies produced in novel production systems, novel separation technologies, novel antibody formats and alternative scaffolds, and strategies for ton-scale manufacturing • Presents new and updated discussions of different purification technologies, focusing on how they can address the capacity crunch in antibody purification • Emphasizes antibodies and innovative chromatography methods for processing |
| developability assessment of therapeutic antibodies: Therapeutic Fc-Fusion Proteins Steven M. Chamow, Thomas Ryll, Henry B. Lowman, Deborah Farson, 2013-12-18 Edited by three pioneers in the field, each with longstanding experience in the biotech industry, and a skilled scientific writer, this is the first book to cover every step in the development and production of immunoglobulin Fc-fusion proteins as therapeutics for human disease: from choosing the right molecular design, to pre-clinical characterization of the purified product, through to batch optimization and quality control for large-scale cGMP production. The whole of the second part is devoted to case studies of Fc-fusion proteins that are now commercially successful products. In this section, the authors, several of whom were personally involved in clinical development of the products themselves, detail the product?s background and give insight into issues that were faced and how these issues were overcome during clinical development. This section also includes a chapter on promising new developments for the future. An invaluable resource for professionals already working on Fc-fusion proteins and an excellent and thorough introduction for physicians, researchers, and students entering the field. |
| developability assessment of therapeutic antibodies: Deamidation and Isoaspartate Formation in Peptides and Proteins Dana W. Aswad, 1995 As the biotechnology industry provides an increasing number of protein-based pharmaceuticals, it is important to understand the sources of heterogeneity and instability of purified proteins. Deamidation and Isoaspartate Formation in Peptides and Proteins focuses exclusively on these topics. It provides a comprehensive presentation of the mechanisms and conditions that lead to deamidation and isoaspartate formation, the effect of protein structure on the susceptibility of proteins to these reactions, the functional consequences of these reactions, and methodology that can be used to assess the amount and location of these damage reactions in proteins. The thirteen chapters, all written by highly respected experts, cover general reviews, case studies, and methodology. Numerous tables throughout the text provide quick access to precise data. For example, Table 1 in Chapter 13-Proteins that Deamidate Nonenzymatically-provides a significant source of protein information due to the endless research and dedication of its author, H.T. Wright. The information in this invaluable book is useful in evaluating alternative purification procedures, analyzing product purity, optimizing formulation and storage conditions, and designing modified proteins with altered stability characteristics. |
| developability assessment of therapeutic antibodies: Handbook of Therapeutic Antibodies Stefan Dübel, Janice M. Reichert, 2014-12-03 Dieses Nachschlagewerk zu therapeutischen Antikörpern sucht auch in der komplett überarbeiteten 2. Auflage seinesgleichen und bietet 30 % neue Inhalte zu Entwicklung, Herstellung und therapeutischen Anwendungen dieser Biomoleküle. |
| developability assessment of therapeutic antibodies: Quality by Design for Biopharmaceuticals Anurag S. Rathore, Rohin Mhatre, 2011-09-20 The concepts, applications, and practical issues of Quality by Design Quality by Design (QbD) is a new framework currently being implemented by the FDA, as well as EU and Japanese regulatory agencies, to ensure better understanding of the process so as to yield a consistent and high-quality pharmaceutical product. QbD breaks from past approaches in assuming that drug quality cannot be tested into products; rather, it must be built into every step of the product creation process. Quality by Design: Perspectives and Case Studies presents the first systematic approach to QbD in the biotech industry. A comprehensive resource, it combines an in-depth explanation of basic concepts with real-life case studies that illustrate the practical aspects of QbD implementation. In this single source, leading authorities from the biotechnology industry and the FDA discuss such topics as: The understanding and development of the product's critical quality attributes (CQA) Development of the design space for a manufacturing process How to employ QbD to design a formulation process Raw material analysis and control strategy for QbD Process Analytical Technology (PAT) and how it relates to QbD Relevant PAT tools and applications for the pharmaceutical industry The uses of risk assessment and management in QbD Filing QbD information in regulatory documents The application of multivariate data analysis (MVDA) to QbD Filled with vivid case studies that illustrate QbD at work in companies today, Quality by Design is a core reference for scientists in the biopharmaceutical industry, regulatory agencies, and students. |
| developability assessment of therapeutic antibodies: Quality by Design for Biopharmaceutical Drug Product Development Feroz Jameel, Susan Hershenson, Mansoor A. Khan, Sheryl Martin-Moe, 2015-04-01 This volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development. Twenty-eight comprehensive chapters cover dosage forms, liquid and lyophilized drug products. The introductory chapters of this book define key elements of QbD and examine how these elements are integrated into drug product development. These chapters also discuss lessons learned from the FDA Office of Biotechnology Products pilot program. Following chapters demonstrate how QbD is used for formulation development ranging from screening of formulations to developability assessment to development of lyophilized and liquid formats. The next few chapters study the use of small-scale and surrogate models as well as QbD application to drug product processes such as drug substance freezing and thawing, mixing, sterile filtration, filling, lyophilization, inspection and shipping and handling. Later chapters describe more specialized applications of QbD in the drug product realm. This includes the use of QbD in primary containers, devices and combination product development. The volume also explores QbD applied to vaccine development, automation, mathematical modeling and monitoring, and controlling processes and defining control strategies. It concludes with a discussion on the application of QbD to drug product technology transfer as well as overall regulatory considerations and lifecycle management. Quality by Design for Biopharmaceutical Drug Product Development is an authoritative resource for scientists and researchers interested in expanding their knowledge on QbD principles and uses in creating better drugs. |
| developability assessment of therapeutic antibodies: Prediction of Protein Secondary Structure Andrzej Kloczkowski, Lukasz Kurgan, Eshel Faraggi, 2024-11-23 This second edition volume expands on the previous edition with updates on the latest methods, resources, and studies concerning analysis and prediction of various structural and functional aspects of proteins and ncRNAs. The chapters in this book cover topics such as secondary structure characterization and prediction; the use and impact of AI (including AlphaFold, large language models, and deep neural networks) in the protein structure prediction field; methods and resources for the prediction of posttranslational modifications, residue-residue contacts, subcellular localization, intrinsic disorder, protein-ligand interactions, and protein aggregation; analysis of cryo-EM data; and analysis of noncoding RNAs in the context of human diseases. Written in the highly successful Methods in Molecular Biology series format, chapters include introductions and surveys of the respective topics, list the necessary materials and methods, cover step-by-step instructions on how to use predictive tools and interpret their results, and provide tips on troubleshooting and avoiding known pitfalls. Cutting-edge and thorough, Prediction of Protein Secondary Structure, Second Edition is a valuable resource for anyone interested in understanding the dynamic and growing field of the protein structure prediction. |
| developability assessment of therapeutic antibodies: Antibody Engineering Carl A. K. Borrebaeck, 1995 In presenting a practical overview of the engineering of recombinant human or mouse monoclonal antibodies, the book incisively addresses essential topics such as antibody structure relevant to engineering, recombinatorial cDNA libraries, phage display, synthetic and humanized antibodies, engineering of affinity and biological effector functions, and plant, mammalian, and bacterial expression vectors and hosts. Antibody Engineering, Second Edition - written by leading experts and now thoroughly updated - is a unique resource for current information on the subject. |
| developability assessment of therapeutic antibodies: Antibody Engineering Damien Nevoltris, Patrick Chames, 2019-12-10 This detailed new edition provides complete and easy access to a variety of antibody engineering techniques. The volume explores topics such as the generation of native, synthetic, or immune antibody libraries, the selection of lead candidates via the different powerful and innovative display technologies, Fc engineering, as well as their production, characterization, and optimization of antibodies. Written for the highly successful Methods in Molecular Biology series, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Authoritative and up-to-date, Antibody Engineering: Methods and Protocols, Third Edition presents the reader with an extensive toolbox to create the powerful molecules of tomorrow. |
| developability assessment of therapeutic antibodies: Therapeutic Proteins Vladimir Voynov, Justin A. Caravella, 2016-05-01 Emphasizing the newest developments in the field, this volume presents detailed methodswith added emphasison therapeutic protein discovery. It features key tips and valuable implementation advice to ensure successful results. |
| developability assessment of therapeutic antibodies: Antibody Methods and Protocols Gabriele Proetzel, Hilmar Ebersbach, 2012-06-24 The rapidly growing field of antibody research is the result of many advancing technologies allowing current developments to take advantage of molecular engineering to create tailor-made antibodies. Antibody Methods and Protocols attempts to provide insight into the generation of antibodies using in vitro and in vivo approaches, as well as technical aspects for screening, analysis, and modification of antibodies and antibody fragments. The detailed volume is focused on basic protocols for isolating antibodies and, at the same time, it selects a range of specific areas with the aim of providing guides for the overall process of antibody isolation and characterization as well as protocols for enhancing classical antibodies and antibody fragments. Written in the highly successful Methods in Molecular BiologyTM series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Authoritative and easy to use, Antibody Methods and Protocols provides a broad and useful background to support ongoing efforts by novices and experts alike and encourages the development of new imaginative approaches to this vital area of study. |
| developability assessment of therapeutic antibodies: Therapeutic Monoclonal Antibodies Zhiqiang An, 2011-09-20 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. |
| developability assessment of therapeutic antibodies: Antibody Engineering J. Donald Capra, 1997 The last decade has witnessed remarkable developments in antibody research and its therapeutic applications. With the methods of molecular biology it is now possible to manipulate the specificities and activities of antibody molecules to generate an almost limitless array of structures for both basic investigations and the clinical setting. The contributions to this volume cover all three domains of the antibody: the variable regions, the relatively neglected but crucial hinge, and the constant region. These studies provide critical structural and functional information about antibodies, while also pointing the way to the construction of molecules with enhanced or even novel properties. Bringing together major experts on antibody engineering, this book is highly recommended to faculty, postdoctoral fellows and graduate students in molecular biology, microbiology, immunology, cancer research and genetics. |
| developability assessment of therapeutic antibodies: Artificial Intelligence in Drug Design Alexander Heifetz, 2022-11-05 This volume looks at applications of artificial intelligence (AI), machine learning (ML), and deep learning (DL) in drug design. The chapters in this book describe how AI/ML/DL approaches can be applied to accelerate and revolutionize traditional drug design approaches such as: structure- and ligand-based, augmented and multi-objective de novo drug design, SAR and big data analysis, prediction of binding/activity, ADMET, pharmacokinetics and drug-target residence time, precision medicine and selection of favorable chemical synthetic routes. How broadly are these approaches applied and where do they maximally impact productivity today and potentially in the near future. Written in the highly successful Methods in Molecular Biology series format, chapters include introductions to their respective topics, lists of the necessary software and tools, step-by-step, readily reproducible modeling protocols, and tips on troubleshooting and avoiding known pitfalls. Cutting-edge and unique, Artificial Intelligence in Drug Design is a valuable resource for structural and molecular biologists, computational and medicinal chemists, pharmacologists and drug designers. |
| developability assessment of therapeutic antibodies: Pharmaceutical Dosage Forms and Drug Delivery Ram I. Mahato, Ajit S. Narang, 2017-11-22 Completely revised and updated, this third edition of Pharmaceutical Dosage Forms and Drug Delivery elucidates the basic principles of pharmaceutics, biopharmaceutics, dosage form design, and drug delivery – including emerging new biotechnology-based treatment modalities. The authors integrate aspects of physical pharmacy, chemistry, biology, and biopharmaceutics into drug delivery. This book highlights the increased attention that the recent spectacular advances in gene therapy and nanotechnology have brought to dosage form design and drug delivery. With the expiration of older patents and generic competition, the biopharmaceutical industry is evolving faster than ever. Apart from revising and updating existing chapters on the basic principles, this edition highlights the emerging emphasis on drug discovery, antibodies and antibody-drug conjugates as therapeutic moieties, individualized medicine including patient stratification strategies, targeted drug delivery, and the increasing role of modeling and simulation. Although there are numerous books on pharmaceutics and dosage forms, most cover different areas of the discipline and do not provide an integrated approach. The integrated approach of this book not only provides a singular perspective of the overall field, but also supplies a unified source of information for students, instructors and professionals, saving their time and money. |
| developability assessment of therapeutic antibodies: Genotype Phenotype Coupling Stefan Zielonka, Simon Krah, 2023-07-05 This detailed new edition broadens the scope of the first edition by moving beyond classical display technologies. This book explores methodologies for the generation of natively paired antibody libraries, single cell technologies, alternative scaffolds, and in silico antibody sequence assessments are described. The application of these methods may allow for a generation of improved therapeutics and diagnostic reagents in a shorter time frame. Written for the highly successful Methods in Molecular Biology series, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step and readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Authoritative and practical, Genotype Phenotype Coupling: Methods and Protocols, Second Edition serves as an ideal guide for researchers seeking to expand their knowledge of antibody-based therapeutics. |
| developability assessment of therapeutic antibodies: Preclinical Safety Evaluation of Biopharmaceuticals Joy A. Cavagnaro, 2013-03-07 The goal is to provide a comprehensive reference book for the preclinicaldiscovery and development scientist whose responsibilities span target identification, lead candidate selection, pharmacokinetics, pharmacology, and toxicology, and for regulatory scientists whose responsibilities include the evaluation of novel therapies. —From the Afterword by Anthony D. Dayan Proper preclinical safety evaluation can improve the predictive value, lessen the time and cost of launching new biopharmaceuticals, and speed potentially lifesaving drugs to market. This guide covers topics ranging from lead candidate selection to establishing proof of concept and toxicity testing to the selection of the first human doses. With chapters contributed by experts in their specific areas, Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials: Includes an overview of biopharmaceuticals with information on regulation and methods of production Discusses the principles of ICH S6 and their implementation in the U.S., Europe, and Japan Covers current practices in preclinical development and includes a comparison of safety assessments for small molecules with those for biopharmaceuticals Addresses all aspects of the preclinical evaluation process, including: the selection of relevant species; safety/toxicity endpoints; specific considerations based upon class; and practical considerations in the design, implementation, and analysis of biopharmaceuticals Covers transitioning from preclinical development to clinical trials This is a hands-on, straightforward reference for professionals involved in preclinical drug development, including scientists, toxicologists, project managers, consultants, and regulatory personnel. |
| developability assessment of therapeutic antibodies: Rational Design of Stable Protein Formulations John F. Carpenter, Mark C. Manning, 2012-12-06 Recombinant proteins and polypeptides continue to be the most important class of biotechnology-derived agents in today's pharmaceutical industry. Over the past few years, our fundamental understanding of how proteins degrade and how stabilizing agents work has made it possible to approach formulation of protein pharmaceuticals from a much more rational point of view. This book describes the current level of understanding of protein instability and the strategies for stabilizing proteins under a variety of stressful conditions. |
In vitro and in silico assessment of the developability of a …
In vitro and in silico assessment of the developability of a designed monoclonal antibody library Adriana-Michelle Wolf Péreza,b, Pietro Sormanni c, Jonathan Sonne Andersend, Laila Ismail …
Structure, heterogeneity and developability assessment of …
Structure, heterogeneity and developability assessment of therapeutic antibodies Yingda Xua, Dongdong Wangb, Bruce Mason c, Tony Rossomando , Ning Lid, Dingjiang Liu e, Jason K …
Early determination of potential critical quality attributes of ...
The current developability assessment strategy provided comprehensive, precise characterization of antibody binding activity in the stability studies, enabling us to perform correlation analysis ...
Developability Assessment Services - Curia Global
Therapeutic Developability Assessment Packages 1 and 2 Key Features: • Rapid and small-scale assessments for drug candidates In silico analysis can be completed in 1 week Polyspecificity …
Assessment of therapeutic antibody developability by …
REQUIREMENTS FOR THERAPEUTIC ANTIBODY DEVELOPMENT Antibodies for therapeutic applications are required to endure and survive a wide range of stresses related to …
Separating clinical antibodies from repertoire antibodies, a …
developability assessment Christopher Negron , Joyce Fang, Michael J. McPherson, W. Blaine Stine Jr, and Andrew J. McCluskey ... Yet, advancing antibodies into the clinic remains difficult …
Structure-Based Charge Calculations for Predicting Properties …
Antibody developability assessment and optimization Charge calculations and therapeutic profiling in focus1 Target affinity screen Automated antibody modeling Developability assessment …
Current advances in biopharmaceutical informatics: …
Therapeutic monoclonal antibodies and their derivatives are key components of clinical pipelines in the ... tional tools for the “developability assessment” of antibody drug candidates. Here ...
In Silico Approaches to Deliver Better Antibodies by Design …
silico tools for developability assessment of antibody sequences. It is now routine to identify and eliminate or optimize antibody hits with poor developability profiles. To further accelerate …
Current advances in biopharmaceutical informatics: …
Therapeutic monoclonal antibodies and their derivatives are key components of clinical pipelines in the global biopharmaceutical industry. The availability of large datasets of antibody …
Current advances in biopharmaceutical informatics: …
the computational developability assessment of antibody therapeutics Rahul Khetan, Robin Curtis, Charlotte M. Deane, Johannes Thorling Hadsund, Uddipan Kar, Konrad Krawczyk, Daisuke …
Current advances in biopharmaceutical informatics: …
Therapeutic monoclonal antibodies and their derivatives are key components of clinical pipelines in the ... tional tools for the “developability assessment” of antibody drug candidates. Here ...
guidelines, impact and challenges in the computational …
Therapeutic monoclonal antibodies and their derivatives are key components of clinical pipelines in the global biopharmaceutical industry. The availability of large datasets of antibody …
Predicting Antibody Developability Profiles Through Early …
Apr 19, 2020 · Therapeutic monoclonal antibodies (mAbs) represent one of the fastest-growing segments in the pharmaceutical market. Antibody therapeutics enter clinical studies, and are …
Five computational developability guidelines for therapeutic …
AND BIOLOGY Five computational developability guidelines for therapeutic antibody profiling Matthew I. J. Raybould a, Claire Marks , Konrad Krawczyka, Bruck Taddeseb, Jaroslaw …
COMPUTATIONAL DEVELOPABILITY ASSESSMENT OF …
Figure 2: Therapeutic monoclonal antibodies in approved or review stages (1986 - 2022) . 21 Figure 3: Biopharmaceutical Informatics tools for computational developability assessment of …
Antibody discovery & engineering
30 healthy donors. A wide range of high affinity antibodies can be generated without affinity maturation. Multiple antibodies generated from XOMA libraries are in clinical trials. Risk …
Developability assessment at early-stage discovery to enable ...
possible. Assessment of developability at the early discovery stage should be performed in a rapid and high-throughput manner while consuming small amounts of testing materials. In addition to …
Gunnar Houen Editor Therapeutic Antibodies - Springer
Therapeutic antibodies (biologics) are the fastest growing pharmaceutical drug group and ... 4 Assessment of Therapeutic Antibody Developability ... Pe´rez, Nikolai Lorenzen, Michele …
Cutting-edge multi-level analytical and structural …
antibodies and directed against the following antigen targets (i.e., CD19, CD79b, DLL3, ... (3G-ADCs) with extended therapeutic windows [4]. Because of the hybrid nature of ADCs, product …
Label-free Assessment of Complement-Dependent …
May 3, 2024 · values for the tested antibodies. Created with BioRender.com. Leveraging recent strategies for automated MALDI-TOF MS-based cell assays for small-molecule drug-like …
AB-Amy: machine learning aided amyloidogenic risk …
only associated with disease but also the developability of the antibody. A machine learning method for the assessment of therapeutic antibody amyloidosis is herein presented. …
Separating clinical antibodies from repertoire antibodies, a …
Antibody Developability Analysis (TA-DA), Therapeutic Antibody Profiler (TAP), Therapeutic Structural Antibody Database (Thera-SAbDab), Variable Heavy (VH), Variable Light (VL). …
Predicting purification process fit of monoclonal antibodies …
Jan 9, 2025 · evaluation of the ease of development of therapeutic candi-dates (a.k.a. developability assessment) is crucial in ensuring rapid and smooth development timelines. …
0005060697 57..113 - Springer
Assessment of Therapeutic Antibody Developability by Combinations of In Vitro and In Silico Methods Adriana-Michelle Wolf Pe´rez, Nikolai Lorenzen, Michele Vendruscolo, and Pietro …
FLAb: Benchmarking deep learning methods for antibody …
therapeutic potential, resulting in over 150 therapeutic antibodies targeting diverse diseases [4]. The efficacy of therapeutic antibody candidates hinges on achieving a delicate balance of drug …
Separating clinical antibodies from repertoire antibodies, a …
Antibody Developability Analysis (TA-DA), Therapeutic Antibody Profiler (TAP), Therapeutic Structural Antibody Database (Thera-SAbDab), Variable Heavy (VH), Variable Light (VL). …
Early developability screen of therapeutic antibody …
Rh, hydrodynamic radius; S-DAS, selection developability assessment; SEC-LC, size-exclusion liquid chromatography; SF, scaling factor; STD, standard deviation; CV, coefficient of variation …
Developability studies before initiation of process development
hensive set of developability experiments and applied the strategy to a number of monoclonal antibodies (mAbs) currently in our pipeline. This strategy includes a series of in silico and …
Developability Assessment Services - dpm.curiaglobal.com
Therapeutic Developability Assessment Packages 1 and 2 Key Features: • Rapid and small-scale assessments for drug candidates In silico analysis can be completed in 1 week Polyspecificity …
guidelines, impact and challenges in the computational …
the computational developability assessment of antibody therapeutics Rahul Khetan, Robin Curtis, Charlotte M. Deane, Johannes Thorling Hadsund, Uddipan Kar, Konrad Krawczyk, Daisuke …
Five Computational Developability Guidelines for …
The Therapeutic Antibody Profiler: A structure-based, in silico method for rapidly detecting mAbs with poor developability Assumptions - Many instances of poor developability are caused by …
PROPERMAB: an integrative framework for in silico prediction …
Oct 10, 2024 · developability assessment. We developed a computational framework, PROPERMAB, for large-scale and eUicient in silico prediction of developability properties for …
Holistic in silico developability assessment of novel classes …
Holistic in silico developability assessment of novel classes of small proteins using publicly available sequence‑based predictors ... IgG-based therapeutic antibodies. Their ability to …
Assessment and incorporation of in vitro correlates to …
Jul 31, 2024 · As antibodies continue to grow as a therapeutic drug class, it is important to streamline the processes leading to the identifica- ... This developability assessment has …
Accelerated Formulation Development of Monoclonal …
Biotherapeutic products based on monoclonal antibodies (mAbs) are the fastest growing category of therapeutics entering clinical study.1,2 Since the first introduction of technology to produce …
Developability considerations for bispecific and multispecific …
Developability considerations for bispecific and multispecific antibodies Alaa Amasha, ... Early assessment of candidate developability enables demotion of antibodies ... allow novel …
Monoclonal Antibodies - gmp-compliance.org
Developability assessment and early formulation screenings Phase appropriate formulation strategies for mAbs Conducting stability studies: protocols, parameters and analytical methods …
0005060697 57..113 - Springer
Assessment of Therapeutic Antibody Developability by Combinations of In Vitro and In Silico Methods Adriana-Michelle Wolf Pe´rez, Nikolai Lorenzen, Michele Vendruscolo, and Pietro …
A translational perspective: Biacore™ systems in discovery
hormones, cytokines, and therapeutic antibodies were developed by academics and advanced by translational scientists for the treatment of diseases including diabetes, cancer, and rheumatic …
Selection of bispecific antibodies with optimal …
of serum half-life prior to clinical assessment. FcRn high-performance liquid chromatography (HPLC) assays FcRn binding of therapeutic IgGs across a pH gradient, allowing the correlation …
Separating clinical antibodies from repertoire antibodies, a …
gonality into a single model referred to as the Therapeutic Antibody Developability Analysis (TA-DA). On a hold-out test set, this tool separated clinical antibodies from repertoire antibodies …
Predicting purification process fit of monoclonal antibodies …
Aug 5, 2024 · In early stage development of therapeutic monoclonal antibodies, assessment of ease of purification process development typically requires extensive experimentation. …
Label-free Assessment of Complement-Dependent …
May 3, 2024 · values for the tested antibodies. Created with BioRender.com. Leveraging recent strategies for automated MALDI-TOF MS-based cell assays for small-molecule drug-like …
AbNatiV: VQ-VAE-based assessment of antibody and …
Apr 28, 2023 · majority of therapeutic antibodies continues to come from animal immunization 18. This consideration thus raises the question of whether a computational design strategy will …
Developability Assessment Services - dpm.curiaglobal.com
Developability: Assess the Path to Product LakePharma offers developability studies for antibody drug candidates with promising biochemical and biophysical properties. Discovery Engineering …
Assessment and incorporation of in vitro correlates to …
As antibodies continue to grow as a therapeutic drug class, it is important to streamline the processes leading to the identifica- ... This developability assessment has gained importance …
A G D FRAMEWORK FOR THE OPTIMIZA THERAPEUTIC LIKE …
evaluates and optimizes antibodies for developability without requiring structure prediction or physics-based computation. TherAbDesign proposes rational mod-ifications to mimic the …
Developability Assessment Services - dpm.curiaglobal.com
Developability: Assess the Path to Product LakePharma offers developability studies for antibody drug candidates with promising biochemical and biophysical properties. Discovery Engineering …
A case study of a bispecific antibody manufacturability …
Bispecific antibodies (bsAbs) have gained significant attention in the biopharmaceutical field due to their capability to target two different targets or two epitopes on one antigen, potentially …
