Monoclonal Antibodies: Physicochemical Analysis

Harleen Kaur · Dietmar Reusch

aug. 2021 · Elsevier

E-bok

258

Sidor

Kvalificerad

Betyg och recensioner verifieras inte Läs mer

Om den här e-boken

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

Om författaren

Dr. Harleen Kaur research focuses on the development and characterization of large molecules, particularly monoclonal antibodies (mAbs) and bringing therapeutic molecules from early discovery and research stage to commercialization. Dr Kaur has previously worked for AstraZeneca and WuXi Biologics in the United States and has extensive experience in the development and testing of biologics as therapeutic molecules in a highly regulated environment. She earned her undergraduate degree from Guru Gobind Singh Indraprastha University, India, and PhD degree from the National University of Singapore, Singapore. Dr Kaur is the author of many peer-reviewed publications and book chapters in the area of antibody characterization and aptamers. She is also the lead editor of the book titled “Monoclonal Antibodies: Physicochemical Analysis that was published by Elsevier.

Dietmar Reusch, PhD, is affiliated with Roche Diagnostics GmbH in Germany. His research focuses on the analytical development and characterization of large molecules, particularly mAbs, and on bringing therapeutic products from entry into human to commercial launch.

Betygsätt e-boken

Berätta vad du tycker.

Läsinformation

Smartphones och surfplattor

Installera appen Google Play Böcker för Android och iPad/iPhone. Appen synkroniseras automatiskt med ditt konto så att du kan läsa online eller offline var du än befinner dig.

Laptops och stationära datorer

Du kan lyssna på ljudböcker som du har köpt på Google Play via webbläsaren på datorn.

Läsplattor och andra enheter

Om du vill läsa boken på enheter med e-bläck, till exempel Kobo-läsplattor, måste du ladda ned en fil och överföra den till enheten. Följ anvisningarna i hjälpcentret om du vill överföra filerna till en kompatibel läsplatta.

Rapportera olagligt innehåll