An Introduction to Bioanalysis of Biopharmaceuticals by Seema Kumar Paperback Bo

Description: An Introduction to Bioanalysis of Biopharmaceuticals by Seema Kumar The book provides a comprehensive review of the fundamental and practical aspects of bioanalytical support and the integral role it plays in the development of safe and efficacious biopharmaceutical drugs with speed and cost-effectiveness. The book focuses on a broad range of conventional and emerging biopharmaceutical modalities including monoclonal antibody-based therapeutics, gene therapy, cell therapy, peptides and oligonucleotides. The book starts with an introductory overview of bioanalysis showcasing the integral role it plays in understanding the drug disposition (pharmacokinetics/pharmacodynamics and immunogenicity) and the progression of bioanalytical strategy as the drug progresses through discovery and development stages of the program, taking into consideration the continually evolving regulatory landscape. The book further diversifies into individual biopharmaceutical modalities - monoclonal antibodies, antibody-drug conjugates, bispecifics, Fc-fusion proteins, gene therapies, cell therapies, peptides and oligonucleotides. The individual chapters focus on modality-specific bioanalytical assay strategies, critical reagents, assay formats, analytical platforms, associated bioanalytical challenges and mitigation strategies, industry best practices, and the latest understanding of regulatory guidance as applicable to the fast-growing biopharmaceutical landscape. FORMAT Paperback CONDITION Brand New Author Biography Seema Kumar is currently Director and senior DMPK lead at EMD Serono Inc. (a business of Merck KGaA, Germany). In her role, Dr. Kumar leads the Clinical Bioanalytical Sciences group that provides Bioanalysis (BA), Immunogenicity and DMPK support for clinical stage large molecule portfolio. Additionally as a senior DMPK lead, Dr. Kumar provides overall drug disposition support for large molecules spanning across discovery and development stages of the program. Previously, Dr. Kumar led regulated Bioanalytical group in BioMedicine Design (formerly PDM) at Pfizer. The group provided regulated (GLP/GCP) BA support including assay development, validation and sample analysis for PK and Immunogenicity (ADA and Nab) assessment of Pfizers large molecule portfolio. Prior to joining Pfizer, Dr. Kumar served at roles of increasing responsibility as Director of Quality Control and Director of CLIA certified Clinical Bioanalytical Lab at XBiotech USA Inc. Dr. Kumar holds a Ph.D. from Johns Hopkins University and has published several publications in peer-reviewed journals and contributed to several book chapters. Dr. Kumar has given numerous invited talks in various national and international scientific conferences and meetings and is an active member of industry consortia (IQ, AAPS etc.).. Table of Contents Bioanalytical Support in Drug Discovery and Development,- Monoclonal Antibodies.- Antibody Drug Conjugates (ADCS).- Bispecifics and Fusion Proteins.- Emerging Modalities-Part A- (Gene Therapy and Cell Therapy).- Emerging Modalities Part B (Peptides, Oligonucleotide Based Therapy, Vaccines. Details ISBN303099998X Author Seema Kumar Publisher Springer Nature Switzerland AG Edition Description 1st ed. 2022 Series AAPS Advances in the Pharmaceutical Sciences Series Year 2023 Edition 1st ISBN-13 9783030999988 Format Paperback Imprint Springer Nature Switzerland AG Place of Publication Cham Country of Publication Switzerland Alternative 9783030971922 Edited by Seema Kumar DEWEY 615.7 Series Number 57 Audience Professional & Vocational Pages 160 Illustrations 19 Illustrations, color; 6 Illustrations, black and white; IX, 160 p. 25 illus., 19 illus. in color. Publication Date 2023-08-25 We've got this At The Nile, if you're looking for it, we've got it. With fast shipping, low prices, friendly service and well over a million items - you're bound to find what you want, at a price you'll love! TheNile_Item_ID:159690089;

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