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In downstream purification of monoclonal antibodies (MAbs), the single greatest contributor to manufacturing costs is the expensive capture step typically based on protein A affinity chromatography. Almost since its introduction to bioprocessing, efforts have been made to reduce the cost of this step.
Continuous Manufacturing: A Changing Processing Paradigm
Although continuous manufacturing is well established for bulk chemicals, complex automation and validation challenges limit continuous applications for biologics manufacturing. While only a few approved biologic products in the market-less than 10%, according to estimates by Eric Langer, managing partner, BioPlan Associates-are manufactured through perfusion or continuous downstream processing, the field is evolving (1). Most of these processes are done piecewise, however, and are not truly continuous.
E-book Volume 2 February 2018 Compiled by John Bonham-Carter, Repligen Chapters Introduction to Continuous Bioprocessing: Current Status and Trends Eric S. Langer, BioPlan Associates, Inc. and and Ronald A. Rader How to Develop a Perfusion Process Véronique Chotteau, Royal Institute of Technology (KTH) Strategies for development of perfusion media Delia Lyons, MilliporeSigma and Jochen Sieck, Merck KGaA Perfusion Application in Mobius® Single-use Bioreactors Michael Cunningham and Douglas Rank, MIlliporeSigma XCell ATF® Perfusion Technology Delivers High Throughput: Efficient Seed Train Process with Improved Fed-Batch Production Output W. Roy Lin, Shashi Kudugunti, Mario Sinani, Tim Erlandson and Dr. James Rusche, Repligen Product Quality Considerations of Perfusion Processes Thomas Villiger, Daniel Karst and Massimo Morbidelli, ETH Zurich Impurity Monitoring as Novel PAT Tool for Continuous Biopharmaceutical Processes Vignesh Rajamanickam, Dr. Patrick Sagmeister, Oliver Spadiut, and Christoph Herwig, TU Wien Austria Insect Cells and ATF Willem Adriaan (Wian) de Jongh, PhD, ExpreS2ion Biotechnologies Scale up and Technology Transfer in a Continuous Processing Environment Sadettin S. Ozturk, Ph.D., Massbiologics Continuous Multicolumn Chromatography Processes Marc Bisschops, Pall Corporation Impact of Single‑use Technology on Continuous Bioprocessing William G. Whitford, GE Healthcare Continuous Bioprocessing's Impact on Facility Design Morten Munk, NNE A/S
Continuous Bioprocessing: Current Practice And Future Potential
E-book Volume 1 2014 Compiled by John Bonham-Carter, Repligen Chapters Introduction to Continuous Manufacturing:Technology Landscape and Trends Eric S. Langer and Ronald A. Rader, BioPlan Associates A Brief History of Perfusion Biomanufacturing Jerry Shevitz and John Bonham-Carter, Refine Technology Bioreactor Configuration and Operation Christel Fenge, Jörg Weyand, Gerhard Greller, Thorsten Adams, Sartorius Stedim Biotech How to Develop a Perfusion Process Véronique Chotteau, Royal Technical University, KTH Case Study: Optimized Perfusion Shaun Eckerle, Gallus BioPharmaceuticals Process Intensification Approaches for Cost Sensitive Protein Applications Willem Adriaan de Jongh, Expres2ion Biotechnologies Impact of Single-use Technology on Continuous Biorocessing William G. Whitford, Thermo Fisher Scientific Continuous Multicolumn Chromatography Processes Marc Bisschops, Tarpon Biosystems Continuous Processes: Economic Evaluation Andrew Sinclair and Andrew Brown, BioPharm Services Vision: Integrating Upstream and Downstream in a Fully Continuous Facility Tim Johnson, Genzyme