Process Scale Purification of Antibodies

Stay on the cutting edge of antibody purification with the insights of industry experts

Biopharmaceutical companies are under extreme pressure to develop robust and economical large–scale processes while consistently meeting regulatory standards for safety and purity. Unfortunately, while upstream productivity has increased in line with demand, downstream processing is mired in a technology crisis resulting in production bottlenecks. Antibody purification is sandwiched between fermentation and drug formulation, two areas that have traditionally received the lion s share of industry awareness as well as generous research funding and attention in the literature. As a result, improvements in purification technology are needed urgently to meet the challenges of increasing demands without sacrificing product quality.

The second edition of Process Scale Purification of Antibodies continues the legacy of its predecessor to offer scientists, researchers, and engineers an essential resource focused on best practices in manufacturing antibody drugs. It covers different antibody purification strategies, including new developments since the publication of the first edition, and an assembly of top–tier experts in these disparate technologies with the common aim of addressing problems in process–scale antibody purification.

Recognized for providing a fresh perspective on traditional chromatography as well as technologies for the preparation of small molecule drugs, the first edition covered innovative developments in protein purification like smart membranes, bioaffinity mimetics, orthogonal, and integrated strategies and novel platform technologies. The revision updates these topics and also introduces concepts that have gained traction over the ensuing years including the purification of antibodies produced in novel production systems, novel separation technologies, novel antibody formats and alternative scaffolds, and strategies for ton–scale manufacturing.

Process Scale Purification of Antibodies, therefore, consolidates the unique niche occupied by its predecessor and maintains interest in this neglected subject area by promoting the continued, much–needed renaissance in antibody purification.

Uwe Gottschalk, PhD, is Chief Technology Officer at Lonza Pharma / Biotech. Previously, he served as Group Vice President at Bayer Health Care (1991–2004) and Sartorius Stedim Biotech (2004–2014) with varied responsibilities for biopharmaceutical manufacturing and bioseparation–related process technology. Dr. Gottschalk received a doctorate in chemistry from the University of Münster. He is also Head Lecturer at the University of Duisburg–Essen and has written extensively in the areas of biotechnology and somatic gene therapy.