Process Scale Purification of Antibodies by Uwe Gottschalk

Process Scale Purification of Antibodies by Uwe Gottschalk

Solve downstream bottlenecks with expert strategies for antibody purification

With monoclonal antibody sales exceeding $210 billion and upstream productivity outpacing downstream capacity, manufacturers face urgent purification bottlenecks. Process Scale Purification of Antibodies, now in its Third Edition, assembles top-tier technology experts to address process-scale challenges. This established resource delivers practical solutions for each unit operation while maintaining the currency that biopharmaceutical professionals require.

This edition updates protein A chromatography coverage, adds CMC considerations, addresses raw material control strategies, and introduces machine learning and AI applications in purification processes. Contributors provide fresh perspectives on traditional chromatography alongside innovative methods for processing antibodies at scale. The book consolidates proven approaches with emerging technologies to meet increasing production demands without sacrificing product quality.

Readers will also find:

• Comprehensive coverage of purification strategies from leading experts addressing problems specific to each unit operation in antibody manufacturing
• Updated guidance on protein A chromatography optimization and emerging alternatives for process-scale downstream operations in biopharmaceutical production
• New chapters covering CMC considerations and regulatory requirements essential for successful antibody drug development and manufacturing approval
• Practical approaches to raw material control and quality assurance that support robust and economical large-scale purification processes
• Applications of machine learning and artificial intelligence to optimize purification workflows and improve process efficiency in downstream operations

Pharmaceutical and biotech scientists, chemical engineers in biopharmaceutical processing, and professionals in product development or process science departments will find this resource indispensable. Process Scale Purification of Antibodies delivers the technical depth and practical guidance needed to overcome downstream bottlenecks and deliver pure therapeutic antibodies efficiently.

Uwe Gottschalk, PhD, is an Operating Partner at Keensight Capital, a European growth buyout investor specializing in technology and healthcare. Over more than thirty years in biopharmaceutical manufacturing, he held senior positions at Lonza, Sartorius, and Bayer, building extensive expertise in downstream processing technologies and large-scale purification operations. His career spans the full spectrum of antibody production challenges, from process development through commercial manufacturing.