[PDF] State Of The Art And Emerging Technologies For Therapeutic Monoclonal Antibody Characterization eBook

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Approaches to the Purification, Analysis and Characterization of Antibody-Based Therapeutics

Allan Matte
Approaches to the Purification, Analysis and Characterization of Antibody-Based Therapeutics by Allan Matte PDF

Author : Allan Matte
Publisher : Elsevier
Page : 222 pages
File Size : 29,89 MB
Release : 2020-09-07
Category : Business & Economics
ISBN : 0081030193

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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

Monoclonal Antibodies

Harleen Kaur
Monoclonal Antibodies by Harleen Kaur PDF

Author : Harleen Kaur
Publisher : Elsevier
Page : 260 pages
File Size : 40,40 MB
Release : 2021-08-03
Category : Medical
ISBN : 0128223197

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Monoclonal antibodies (mAbs) are naturally occurring complex biomolecules. New engineering methods have turned mAbs into a leading therapeutic modality for addressing immunotherapeutic challenges and led to the rise of mAbs as the dominant class of protein therapeutics. mAbs have already demonstrated a great potential in developing safe and reliable treatments for complex diseases and creating more affordable healthcare alternatives. Developing mAbs into well-characterized antibody therapeutics that meet regulatory expectations, however, is extremely challenging. Obstacles to overcome include the determination and development of physiochemical characteristics such as aggregation, fragmentation, charge variants, identity, carbohydrate structure, and higher-order structure (HOS). This book dives deep into mAbs structure and the array of physiochemical testing and characterization methods that need to be developed and validated to establish a mAb as a therapeutic molecule. The main focus of this book is on physiochemical aspects, including the importance of establishing quality attributes such as glycosylation, primary sequence, purity, and HOS and elucidating the structure of new antibody formats by mass spectrometry. Each of the aforementioned quality attributes has been discussed in detail; this will help scientists in researching and developing biopharmaceuticals and biosimilars to find practical solutions to physicochemical testing and characterization. Describes the spectrum of analytical tests and characterization methods necessary for developing and releasing mAb batches Details antibody heterogeneity in terms of size, charge, and carbohydrate content Gives special focus to the structural analysis of mAbs, including mass spectrometry analysis Presents the basic structure of mAbs with clarity and rigor Addresses regulatory guidelines - including ICH Q6B - in relation to quality attributes Lays out characterization and development case studies including biosimilars and new antibody formats

An Assessment of the National Institute of Standards and Technology Material Measurement Laboratory

National Academies of Sciences, Engineering, and Medicine
An Assessment of the National Institute of Standards and Technology Material Measurement Laboratory by National Academies of Sciences, Engineering, and Medicine PDF

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
Page : 105 pages
File Size : 45,30 MB
Release : 2017-12-29
Category : Technology & Engineering
ISBN : 0309469473

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An Assessment of the National Institute of Standards and Technology Material Measurement Laboratory: Fiscal Year 2017 assesses the scientific and technical work performed by the National Institute of Standards (NIST). This publication reviews technical reports and technical program descriptions prepared by NIST staff summarizes the findings of the authoring panel.

Biosimilars of Monoclonal Antibodies

Cheng Liu
Biosimilars of Monoclonal Antibodies by Cheng Liu PDF

Author : Cheng Liu
Publisher : John Wiley & Sons
Page : 723 pages
File Size : 30,99 MB
Release : 2016-12-09
Category : Medical
ISBN : 1118940628

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Addressing a significant need by describing the science and process involved to develop biosimilars of monoclonal antibody (mAb) drugs, this book covers all aspects of biosimilar development: preclinical, clinical, regulatory, manufacturing. • Guides readers through the complex landscape involved with developing biosimilar versions of monoclonal antibody (mAb) drugs • Features flow charts, tables, and figures that clearly illustrate processes and makes the book comprehensible and accessible • Includes a review of FDA-approved mAb drugs as a quick reference to facts and useful information • Examines new technologies and strategies for improving biosimilar mAbs