Approaches to the Purification Analysis and Characterization of Antibody Based Therapeutics

Approaches to the Purification  Analysis and Characterization of Antibody Based Therapeutics
Author: Allan Matte
Publsiher: Elsevier
Total Pages: 222
Release: 2020-09-07
ISBN: 0081030193
Category: Business & Economics
Language: EN, FR, DE, ES & NL

Approaches to the Purification Analysis and Characterization of Antibody Based Therapeutics Book Excerpt:

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
Author: Jennie R. Lill,Wendy Sandoval
Publsiher: John Wiley & Sons
Total Pages: 368
Release: 2017-07-14
ISBN: 1119384400
Category: Science
Language: EN, FR, DE, ES & NL

Analytical Characterization of Biotherapeutics Book Excerpt:

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.

Protein and Peptide Mass Spectrometry in Drug Discovery

Protein and Peptide Mass Spectrometry in Drug Discovery
Author: Michael L. Gross,Guodong Chen,Birendra Pramanik
Publsiher: John Wiley & Sons
Total Pages: 484
Release: 2011-09-26
ISBN: 1118116542
Category: Medical
Language: EN, FR, DE, ES & NL

Protein and Peptide Mass Spectrometry in Drug Discovery Book Excerpt:

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
Author: Igor A. Kaltashov,Guanbo Wang,Shunhai Wang
Publsiher: Walter de Gruyter GmbH & Co KG
Total Pages: 280
Release: 2021-11-22
ISBN: 3110546183
Category: Science
Language: EN, FR, DE, ES & NL

Mass Spectrometry in Biopharmaceutical Analysis Book Excerpt:

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.

Analysis of Aggregates and Particles in Protein Pharmaceuticals

Analysis of Aggregates and Particles in Protein Pharmaceuticals
Author: Hanns-Christian Mahler,Wim Jiskoot
Publsiher: John Wiley & Sons
Total Pages: 464
Release: 2011-12-20
ISBN: 1118150562
Category: Medical
Language: EN, FR, DE, ES & NL

Analysis of Aggregates and Particles in Protein Pharmaceuticals Book Excerpt:

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.

Index Medicus

Index Medicus
Author: Anonim
Publsiher: Unknown
Total Pages: 135
Release: 2003
ISBN: 1928374650XXX
Category: Medicine
Language: EN, FR, DE, ES & NL

Index Medicus Book Excerpt:

Characterization of Biotherapeutic Products

Characterization of Biotherapeutic Products
Author: Anurag S. Rathore,Christopher Mark Smales,Andras Guttman
Publsiher: Frontiers Media SA
Total Pages: 129
Release: 2022-11-10
ISBN: 2832504752
Category: Science
Language: EN, FR, DE, ES & NL

Characterization of Biotherapeutic Products Book Excerpt:

Development of Antibody Based Therapeutics

Development of Antibody Based Therapeutics
Author: Mohammad A. Tabrizi,Gadi G. Bornstein,Scott L. Klakamp
Publsiher: Springer Science & Business Media
Total Pages: 426
Release: 2012-04-24
ISBN: 1441959556
Category: Medical
Language: EN, FR, DE, ES & NL

Development of Antibody Based Therapeutics Book Excerpt:

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
Author: Anonim
Publsiher: Academic Press
Total Pages: 296
Release: 2017-06-16
ISBN: 0128121777
Category: Science
Language: EN, FR, DE, ES & NL

Advances in Clinical Chemistry Book Excerpt:

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

Process Validation in Manufacturing of Biopharmaceuticals Third Edition

Process Validation in Manufacturing of Biopharmaceuticals  Third Edition
Author: Anurag S. Rathore,Gail Sofer
Publsiher: CRC Press
Total Pages: 535
Release: 2012-05-09
ISBN: 1439850933
Category: Medical
Language: EN, FR, DE, ES & NL

Process Validation in Manufacturing of Biopharmaceuticals Third Edition Book Excerpt:

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 final form on January 24, 2011. The book also provides guidelines and current practices, as well as industrial case studies illustrating the different approaches that can be taken for successful validation of biopharmaceutical processes. Case studies include Process validation for membrane chromatography Leveraging multivariate analysis tools to qualify scale-down models A matrix approach for process validation of a multivalent bacterial vaccine Purification validation for a therapeutic monoclonal antibody expressed and secreted by Chinese Hamster Ovary (CHO) cells Viral clearance validation studies for a product produced in a human cell line A much-needed resource, this book presents process characterization techniques for scaling down unit operations in biopharmaceutical manufacturing, including chromatography, chemical modification reactions, ultrafiltration, and microfiltration. It also provides practical methods to test raw materials and in-process samples. Stressing the importance of taking a risk-based approach towards computerized system compliance, this book will help you and your team ascertain process validation is carried out and exceeds expectations.

Cumulated Index Medicus

Cumulated Index Medicus
Author: Anonim
Publsiher: Unknown
Total Pages: 1836
Release: 2000
ISBN: 1928374650XXX
Category: Medicine
Language: EN, FR, DE, ES & NL

Cumulated Index Medicus Book Excerpt:

Targeting the Microenvironment Niche in Solid and Hematologic Malignancies Basic and Translational Research

Targeting the Microenvironment Niche in Solid and Hematologic Malignancies  Basic and Translational Research
Author: Cirino Botta,Marco Rossi,Niccolò Bolli,Niels Weinhold
Publsiher: Frontiers Media SA
Total Pages: 163
Release: 2022-02-28
ISBN: 2889745414
Category: Medical
Language: EN, FR, DE, ES & NL

Targeting the Microenvironment Niche in Solid and Hematologic Malignancies Basic and Translational Research Book Excerpt:

Current Research on Pre clinical Aspects of Cancer Therapy

Current Research on Pre clinical Aspects of Cancer Therapy
Author: Current Cancer Research Project Analysis Center (U.S.)
Publsiher: Unknown
Total Pages: 275
Release: 1975
ISBN: 1928374650XXX
Category: Cancer
Language: EN, FR, DE, ES & NL

Current Research on Pre clinical Aspects of Cancer Therapy Book Excerpt:

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.

Subject Index of Current Extramural Research Administered by the National Cancer Institute

Subject Index of Current Extramural Research Administered by the National Cancer Institute
Author: Anonim
Publsiher: Unknown
Total Pages: 135
Release: 1978
ISBN: 1928374650XXX
Category: Cancer
Language: EN, FR, DE, ES & NL

Subject Index of Current Extramural Research Administered by the National Cancer Institute Book Excerpt:

Protein Engineering for Therapeutics Part A

Protein Engineering for Therapeutics  Part A
Author: K. Dane Professor Wittrup,Gregory L. Professor Verdine
Publsiher: Academic Press
Total Pages: 394
Release: 2012-01-11
ISBN: 0124160395
Category: Medical
Language: EN, FR, DE, ES & NL

Protein Engineering for Therapeutics Part A Book Excerpt:

These two volumes of Methods in Enzymology cover engineering approaches to the development of protein biopharmaceuticals, which represent a significant and rapidly growing proportion of drug sales. Particular advantages of proteins as drugs relative to small organic molecules include high affinity and specificity afforded by a larger molecular recognition surface and much lower probability of off-target toxicities due to metabolic byproducts. The primary disadvantage to date has been the pharmacokinetic inaccessibility of intracellular drug targets to proteins and peptides, although vigorous efforts at overcoming this limitation are beginning to bear fruit

Developability of Biotherapeutics

Developability of Biotherapeutics
Author: Sandeep Kumar,Satish Kumar Singh
Publsiher: CRC Press
Total Pages: 297
Release: 2015-11-18
ISBN: 1482246155
Category: Medical
Language: EN, FR, DE, ES & NL

Developability of Biotherapeutics Book Excerpt:

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.

Research Awards Index

Research Awards Index
Author: Anonim
Publsiher: Unknown
Total Pages: 1424
Release: 1984
ISBN: 1928374650XXX
Category: Medicine
Language: EN, FR, DE, ES & NL

Research Awards Index Book Excerpt:

Biological Drug Products

Biological Drug Products
Author: Wei Wang,Manmohan Singh
Publsiher: John Wiley & Sons
Total Pages: 744
Release: 2013-08-29
ISBN: 1118695224
Category: Medical
Language: EN, FR, DE, ES & NL

Biological Drug Products Book Excerpt:

Tested and proven solutions to the challenges of biologicaldrug product development Biological drug products play a central role in combating humandiseases; however, developing new successful biological drugspresents many challenges, including labor intensive productionprocesses, tighter regulatory controls, and increased marketcompetition. This book reviews the current state of the science,offering readers a single resource that sets forth the fundamentalsas well as tested and proven development strategies for biologicaldrugs. Moreover, the book prepares readers for the challenges thattypically arise during drug development, offering straightforwardsolutions to improve their ability to pass through all theregulatory hurdles and deliver new drug products to the market. Biological Drug Products begins with generalconsiderations for the development of any biological drug productand then explores the strategies and challenges involved in thedevelopment of specific types of biologics. Divided into fiveparts, the book examines: Part 1: General Aspects Part 2: Proteins and Peptides Part 3: Vaccines Part 4: Novel Biologics Part 5: Product Administration/Delivery Each chapter has been prepared by one or more leading experts inbiological drug development. Contributions are based on acomprehensive review and analysis of the current literature as wellas the authors' first-hand experience developing and testing newdrugs. References at the end of each chapter serve as a gateway tooriginal research papers and reviews in the field. By incorporating lessons learned and future directions forresearch, Biological Drug Products enables pharmaceuticalscientists and students to improve their success rate in developingnew biologics to treat a broad range of human diseases.

Kidney Disease and Nephrology Index

Kidney Disease and Nephrology Index
Author: Anonim
Publsiher: Unknown
Total Pages: 135
Release: 1979
ISBN: 1928374650XXX
Category: Kidneys
Language: EN, FR, DE, ES & NL

Kidney Disease and Nephrology Index Book Excerpt:

Nonclinical Development of Novel Biologics Biosimilars Vaccines and Specialty Biologics

Nonclinical Development of Novel Biologics  Biosimilars  Vaccines and Specialty Biologics
Author: Lisa Plitnick,Danuta Herzyk
Publsiher: Academic Press
Total Pages: 432
Release: 2013-06-27
ISBN: 0123948231
Category: Medical
Language: EN, FR, DE, ES & NL

Nonclinical Development of Novel Biologics Biosimilars Vaccines and Specialty Biologics Book Excerpt:

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