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.

Autorentext

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 Pfizer's 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.)..

Inhalt

Contents

• 1. Bioanalytical Support in Drug-Discovery & Development

  Sanjeev Bhardwaj, Inderpal Singh and Matthew Halquist

• 2. Monoclonal Antibodies

  Sanjeev Bhardwaj, Omnia A. Ismaiel and Varun Ramani

• 3. Antibody-drug conjugates

  Morse Faria, Varun Ramani and Seema Kumar

• 4. Bispecifics and Fusion proteins

  Kelly Covert, Hongmei Niu and Sanjeev Bhardwaj

• 5. Emerging Modalities - Gene and Cell Therapy

  Darshana Jani, Ramakrishna Boyanapalli and Liching Cao

• 6. Emerging Modalities - Peptides and Oligonucleotides

  Inderpal Singh and Ramakrishna Boyanapalli