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Approaches To The Purification Analysis And Characterization Of Antibody Based Therapeutics

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Approaches to the Purification Analysis and Characterization of Antibody Based Therapeutics

Approaches to the Purification  Analysis and Characterization of Antibody Based Therapeutics Book
Author : Allan Matte
Publisher : Elsevier
Release : 2020-09-07
ISBN : 0081030193
Language : En, Es, Fr & De

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Book Description :

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. Covers the vital new area of R&D on therapeutic antibodies Written by leading scientists and researchers Up-to-date coverage and includes a detailed bibliography

Analytical Characterization of Biotherapeutics

Analytical Characterization of Biotherapeutics Book
Author : Jennie R. Lill,Wendy Sandoval
Publisher : John Wiley & Sons
Release : 2017-08-14
ISBN : 1119053102
Language : En, Es, Fr & De

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Book Description :

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.

Analysis of Aggregates and Particles in Protein Pharmaceuticals

Analysis of Aggregates and Particles in Protein Pharmaceuticals Book
Author : Hanns-Christian Mahler,Wim Jiskoot
Publisher : John Wiley & Sons
Release : 2011-12-20
ISBN : 1118150562
Language : En, Es, Fr & De

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Book Description :

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.

Protein and Peptide Mass Spectrometry in Drug Discovery

Protein and Peptide Mass Spectrometry in Drug Discovery Book
Author : Michael L. Gross,Guodong Chen,Birendra Pramanik
Publisher : John Wiley & Sons
Release : 2011-09-26
ISBN : 1118116542
Language : En, Es, Fr & De

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Book Description :

The book that highlights mass spectrometry and its application in characterizing proteins and peptides in drug discovery An instrumental analytical method for quantifying the mass and characterization of various samples from small molecules to large proteins, mass spectrometry (MS) has become one of the most widely used techniques for studying proteins and peptides over the last decade. Bringing together the work of experts in academia and industry, Protein and Peptide Mass Spectrometry in Drug Discovery highlights current analytical approaches, industry practices, and modern strategies for the characterization of both peptides and proteins in drug discovery. Illustrating the critical role MS technology plays in characterizing target proteins and protein products, the methods used, ion mobility, and the use of microwave radiation to speed proteolysis, the book also covers important emerging applications for neuroproteomics and antigenic peptides. Placing an emphasis on the pharmaceutical industry, the book stresses practice and applications, presenting real-world examples covering the most recent advances in mass spectrometry, and providing an invaluable resource for pharmaceutical scientists in industry and academia, analytical and bioanalytical chemists, and researchers in protein science and proteomics.

Mass Spectrometry in Biopharmaceutical Analysis

Mass Spectrometry in Biopharmaceutical Analysis Book
Author : Igor A. Kaltashov,Guanbo Wang,Shunhai Wang
Publisher : Walter de Gruyter GmbH & Co KG
Release : 2021-11-22
ISBN : 3110546183
Language : En, Es, Fr & De

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Book Description :

Biopharmaceuticals are a unique class of compounds due to their extreme structural complexity. The current text puts together a variety of the state‐of‐the art approaches that use mass spectrometry to evaluate various aspects of biopharmaceutical products ranging from monitoring stress‐related structural changes to their quantitation in pharmacokinetic studies.

Immunological Approaches to the Diagnosis and Therapy of Breast Cancer

Immunological Approaches to the Diagnosis and Therapy of Breast Cancer Book
Author : G.P. Talwar
Publisher : Springer Science & Business Media
Release : 2012-12-06
ISBN : 146131903X
Language : En, Es, Fr & De

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Book Description :

Once again we have gathered to discover and evaluate advances made in our ability to understand. diagnose and possibly treat breast cancer with the new reagents provided by monoclonal antibody techniques. In the last two years since our first International Workshop on Monoclonal Antibodies and Breast Cancer there has been an enormous surge in the number and quality of applications for these new reagents. Solid achievements have been made in identification and quantitation of estrogen and progesterone receptors. in histopathological diagnostic procedures. in serum diagnosis. and we are witnessing now the first attempts to treat breast cancer with immunoconjugates. Cytosolic estrogen receptors can now be quantitated with monoclonal antibodies. and also their cellular distribution can be directly assessed histologically. In addition. monoclonal antibodies to progesterone receptors have been generated that show promise in having similar uses as those to the estrogen receptor. In the field of diagnosis. the use of monoclonal antibodies has permitted the development of serological approaches for early diagnosis by identifying and measuring breast epithelial antigens in serum. and of histological approaches for establishing criteria for breast cancer dissemination and prognosis. With great expectations we are all following developments in the area of breast cancer treatment using conjugates of anti-breast epithelial monoclonal antibodies which are now confirming earlier reports in affecting breast tumor control. The recent creation of newer monoclonal antibodies and conjugates await experimentation and clinical trials to determine their value.

Development of Antibody Based Therapeutics

Development of Antibody Based Therapeutics Book
Author : Mohammad A. Tabrizi,Gadi G. Bornstein,Scott L. Klakamp
Publisher : Springer Science & Business Media
Release : 2012-04-24
ISBN : 1441959556
Language : En, Es, Fr & De

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Book Description :

Translational strategies for development of antibody-based therapeutics should allow understanding of the relationship between the ‘unit dose’ and ‘unit effect’ with respect to both beneficial and deleterious effects from early stages of development. The flow of information from later to earlier stages of development should provide opportunities to facilitate selection of more effective novel and next-generation drug candidates. Selection and evaluation of relevant biomarkers in early preclinical development in "relevant" animal models should allow for identifying potential risks to humans and establishing safe First-In-Human (FIH) dosing strategies. Hence, integration of knowledge with respect to target antigen properties such as antigen distribution, expression profile, kinetic properties, target pharmacology, antigen isoforms and pharmacological redundancy in health and disease, as well as antibody design criteria, such as antibody isotype, affinity, PK/PD and safety is a critical necessity for the design of effective translational strategies. Additionally, these factors will further offer critical differentiating characteristics for next-generation antibodies, and novel technologies prove instrumental in generation of biosuperior antibody candidates for market entry. This book will examine many important considerations necessary for the design of effective translational strategies during the development of antibody-based therapeutics.

Advances in Clinical Chemistry

Advances in Clinical Chemistry Book
Author : Anonim
Publisher : Academic Press
Release : 2017-06-16
ISBN : 0128121777
Language : En, Es, Fr & De

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Book Description :

Advances in Clinical Chemistry, Volume 81, the latest installment in this internationally acclaimed series, contains chapters authored by world-renowned clinical laboratory scientists, physicians and research scientists. The serial discusses the latest and most up-to-date technologies related to the field of clinical chemistry and is the benchmark for novel analytical approaches in the clinical laboratory. Provides the most up-to-date technologies in clinical chemistry and clinical laboratory science Authored by world renowned clinical laboratory scientists, physicians and research scientist Presents the international benchmark for novel analytical approaches in the clinical laboratory

Application of Liquid Chromatography mass Spectrometry based Protein and Proteomic Analytical Approaches to Chinese Hamster Ovary Cell Based Industrial Biopharmaceutical Production

Application of Liquid Chromatography mass Spectrometry based Protein and Proteomic Analytical Approaches to Chinese Hamster Ovary Cell Based Industrial Biopharmaceutical Production Book
Author : Yuanwei Gao
Publisher : Unknown
Release : 2016
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Therapeutic proteins have emerged rapidly over the past several decades, providing effective and innovative medicines for a wide range of previously refractory human diseases. Chinese hamster ovary (CHO) cells have become the predominant choice as the cellular expression system for such therapeutic production in the biopharmaceutical industry. The high throughput of the protein drug production depends on both the efficient upstream process yielding high product titers and proficient downstream purification with high product recovery and effective impurity removal. Numerous efforts have been made at both of the up- and down-stream processes of CHO-based manufacturing to improve productivity. Although advances have been achieved, many challenges remain. The underlying biology of CHO cell productivity has not been fully understood due to an incomplete biological picture, hampering the efforts of cell cultivation optimization. Moreover, it is challenging to apply the results of cell cultivation development received from the bench-top scale to large scale production bioreactors, since different behaviors of the CHO cell are frequently observed with different bioreactor types and sizes. At the same time, efficient downstream purification is also essential to ensure drug product quality. Considering the potential safety risks to patients, the identification and quantitation of impurity residues in therapeutic proteins, especially host cell proteins (HCP), is of great importance but challenging due to the bulk drug product background. New analytical technologies and strategies which can be applied to the therapeutic protein production process are needed. Liquid chromatography-mass spectrometry (LC-MS)-based approaches are a powerful tool for proteomics and protein analysis, capable of providing the most comprehensive information to date. LC-MS analysis has been extending the depth and accuracy of proteomics study. Global cell constituent analysis or 'Omics, including proteomics and metabolomics, can provide in depth global characterization of CHO cells. A deeper understanding of CHO biology can potentially improve the optimization of manufacturing bioprocesses. Moreover, LC-MS-based methods are also a great candidate for HCP analysis. This dissertation aims at adapting state-of-the art LC-MS-based protein and proteomic approaches to the industrial biopharmaceutical processes, for the benefit of industrial therapeutic drug production. In Chapter 1, the industrial therapeutic protein production platform is introduced as well as the technology of LC-MS-based protein and proteomics analysis. In Chapter 2, a study is presented where a CHO-DG44 production cell line showed different phenotypic behaviors during the scaling-up process when cultured in the production scale (5-KL scale) and bench-top scale (20-L) bioreactors with two copper levels in the culture media for each scale. Relative quantitative proteomics based on high-resolution two dimensional liquid chromatography coupled to tandem mass spectrometry (2D-LC-MS/MS) was applied. Multi-omics including proteomics and metabolomics were employed to study CHO cell systems in order to understand the phenotypic behavior. The results revealed that CHO cells underwent intermittent hypoxia in the large production bioreactor due to the less efficient oxygen transfer and longer mixing times compared to the bench-top scale. This resulted in lower productivity and viability for the production scale. In collaboration with Simion Kreimer, Ph.D. candidate in chemistry at Northeastern, Chapter 3 describes a workflow of HCP analysis in a therapeutic monoclonal antibody, taking the advantage of the high resolution capabilities of the Orbitrap mass spectrometer. A spectral library was developed based on two-dimensional high pH/low pH reversed phase (RP/RP) liquid chromatography coupled to tandem mass spectrometry (LC/MS/MS) with data dependent acquisition (DDA). Then, a novel data independent acquisition-to- parallel reaction monitoring (DIA-to-PRM) approach was developed for HCP identification and quantitative estimation. The methodology is demonstrated to be capable of detecting HCPs at the low ppm level in the bulk product background after purification. Several HCPs were quantified with isotopically labeled peptides as internal standards. The studies described in this dissertation demonstrate the power of LC-MS-based approaches to address biopharmaceutical industry needs, by studying CHO biology as well as evaluating impurities in final product. In future studies, the discovery and method developed in this thesis can be applied to improve biopharmaceutical productivity and quality.

Therapeutic Monoclonal Antibodies

Therapeutic Monoclonal Antibodies Book
Author : Zhiqiang An
Publisher : John Wiley & Sons
Release : 2011-09-20
ISBN : 1118210263
Language : En, Es, Fr & De

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Book Description :

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.

Therapeutic Proteins

Therapeutic Proteins Book
Author : C. Mark Smales,David Cameron James
Publisher : Springer Science & Business Media
Release : 2005
ISBN : 1592599222
Language : En, Es, Fr & De

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Book Description :

This volume contains contributions from leaders in the field of therapeutic protein expression, purification, characterization, formulation and viral inactivation who cover all aspects of protein drug production downstream of the discovery stage. Protocols for the production of therapeutic proteins using a variety of sources are covered. including bacterial and yeast expression systems, insect and mammalian cells. Therapeutic Proteins: Methods and Protocols will prove an invaluable resourse to all those working in the field of therapeutic protein production.

Structural Biology in Drug Discovery

Structural Biology in Drug Discovery Book
Author : Jean-Paul Renaud
Publisher : John Wiley & Sons
Release : 2020-01-27
ISBN : 1118900405
Language : En, Es, Fr & De

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Book Description :

With the most comprehensive and up-to-date overview of structure-based drug discovery covering both experimental and computational approaches, Structural Biology in Drug Discovery: Methods, Techniques, and Practices describes principles, methods, applications, and emerging paradigms of structural biology as a tool for more efficient drug development. Coverage includes successful examples, academic and industry insights, novel concepts, and advances in a rapidly evolving field. The combined chapters, by authors writing from the frontlines of structural biology and drug discovery, give readers a valuable reference and resource that: Presents the benefits, limitations, and potentiality of major techniques in the field such as X-ray crystallography, NMR, neutron crystallography, cryo-EM, mass spectrometry and other biophysical techniques, and computational structural biology Includes detailed chapters on druggability, allostery, complementary use of thermodynamic and kinetic information, and powerful approaches such as structural chemogenomics and fragment-based drug design Emphasizes the need for the in-depth biophysical characterization of protein targets as well as of therapeutic proteins, and for a thorough quality assessment of experimental structures Illustrates advances in the field of established therapeutic targets like kinases, serine proteinases, GPCRs, and epigenetic proteins, and of more challenging ones like protein-protein interactions and intrinsically disordered proteins

Current Research on Pre clinical Aspects of Cancer Therapy

Current Research on Pre clinical Aspects of Cancer Therapy Book
Author : Current Cancer Research Project Analysis Center (U.S.)
Publisher : Unknown
Release : 1975
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

1038 references to research projects being conducted in the United States and elsewhere. Entries arranged under 5 topics, e.g., Preclinical studies of anticancer drugs, Preclinical radiation therapy, and Preclinical immunotherapy. Entriesinclude title, researcher, address, contract number, summary, and supporting agency. Indexes by subjects, investigators, contractors, supporting agencies, and contractor numbers.

Developability of Biotherapeutics

Developability of Biotherapeutics Book
Author : Sandeep Kumar,Satish Kumar Singh
Publisher : CRC Press
Release : 2015-11-18
ISBN : 1482246155
Language : En, Es, Fr & De

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Book Description :

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 modeling techniques that improve the overall process of discovery and development by removing empiricism. The concept of developability involves making rational choices at the pre-clinical stages of biopharmaceutical drug development that could positively impact clinical outcomes. The book also addresses a general lack of awareness of the many different contributions that computation can make to biopharmaceutical drug development. This informative and practical reference is a valuable resource for professionals engaged in industrial research and development, scientists working with regulatory agencies, and pharmacy, medicine, and life science students and educators. It focuses primarily on the developability of monoclonal antibody candidates, but the principles described can also be extended to other modalities such as recombinant proteins, fusion proteins, antibody drug conjugates and vaccines. The book is organized into two sections. The first discusses principles and applications of computational approaches toward discovering and developing biopharmaceutical drugs. The second presents best practices in developability assessments of early-stage biopharmaceutical drug candidates. In addition to raising awareness of the promise of computational research, this book also discusses solutions required to improve the success rate of translating biologic drug candidates into products available in the clinic. As such, it is a rich source of information on current principles and practices as well as a starting point for finding innovative applications of computation towards biopharmaceutical drug development.

Process Validation in Manufacturing of Biopharmaceuticals

Process Validation in Manufacturing of Biopharmaceuticals Book
Author : Anurag S. Rathore,Gail Sofer
Publisher : CRC Press
Release : 2012-05-09
ISBN : 1439850941
Language : En, Es, Fr & De

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Book Description :

Process Validation in Manufacturing of Biopharmaceuticals, Third Edition delves into the key aspects and current practices of process validation. It includes discussion on the final version of the FDA 2011 Guidance for Industry on Process Validation Principles and Practices, commonly referred to as the Process Validation Guidance or PVG, issued in

Protein Engineering for Therapeutics

Protein Engineering for Therapeutics Book
Author : K. Dane Wittrup,Gregory Lawrence Verdine
Publisher : Academic Press
Release : 2012
ISBN : 0124160395
Language : En, Es, Fr & De

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Book Description :

This volume of Methods in Enzymology looks at Protein Engineering for Therapeutics. The chapters provide an invaluable resource for academics, researchers and students alike. With an international board of authors, this volume is split into sections that cover subjects such as Antibodies, Protein conjugates, Peptides, Enzymes and Scaffolds Chapters provide an invaluable resource for academics, researchers and students alike Iinternational board of authors This volume is split into sections that cover subjects such as Antibodies, Protein conjugates, Peptides, Enzymes and Scaffolds

Hemostasis and Thrombosis

Hemostasis and Thrombosis Book
Author : Anonim
Publisher : Unknown
Release : 1972
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Monthly, with annual cumulation. Recurring bibliography from MEDLARS data base. Index medicus format. Entries arranged under subject, review, and author sections. Subject, author indexes.

Nonclinical Development of Novel Biologics Biosimilars Vaccines and Specialty Biologics

Nonclinical Development of Novel Biologics  Biosimilars  Vaccines and Specialty Biologics Book
Author : Lisa Plitnick,Danuta Herzyk
Publisher : Academic Press
Release : 2013-06-27
ISBN : 0123948231
Language : En, Es, Fr & De

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Book Description :

Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics is a complete reference devoted to the nonclinical safety assessment of novel biopharmaceuticals, biosimilars, vaccines, cell and gene therapies and blood products. This book compares and contrasts these types of biologics with one another and with small molecule drugs, while incorporating the most current and essential international regulatory documents. Each section discusses a different type of biologic, as well as early characterization strategies, principles of study design, preclinical pharmacokinetics and pharmacodynamics and preclinical assays. An edited book that is authored by leading experts in the field, this comprehensive reference provides critical insights to all researchers involved in early through late stage biologics. Provides in-depth coverage of the process of nonclinical safety assessment and comprehensive reviews of each type of biopharmaceutical Contains the most pertinent international regulatory guidance documents for nonclinical evaluation Covers early de-risking strategies and designs of safety assessment programs for novel biopharmaceuticals and vaccines, as well as follow-on biologics or "biosimilars" A multi-authored book with chapters written by qualified experts in their respective fields

Biophysics for Therapeutic Protein Development

Biophysics for Therapeutic Protein Development Book
Author : Linda O. Narhi
Publisher : Springer Science & Business Media
Release : 2013-02-26
ISBN : 1461443164
Language : En, Es, Fr & De

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Book Description :

This book can be used to provide insight into this important application of biophysics for those who are planning a career in protein therapeutic development, and for those outside this area who are interested in understanding it better. The initial chapters describe the underlying theory, and strengths and weaknesses of the different techniques commonly used during therapeutic development. The majority of the chapters discuss the applications of these techniques, including case studies, across the product lifecycle from early discovery, where the focus is on identifying targets, and screening for potential drug product candidates, through expression and purification, large scale production, formulation development, lot-to-lot comparability studies, and commercial support including investigations.