Main description:

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.

Contents:

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