Search results for " comparability"

Article Optimizing Cation-Exchange Chromatography with High-Throughput Process Development for mAb Purification
Optimization of each phase in a chromatographic cycle has a positive impact on productivity. By Anna Grönberg An important area of focus for the biopharma industry is the elucidation and dev…

Article Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
The challenges and strategies of assessing and mitigating risk in biopharmaceutical manufacturing are discussed. Jul 01, 2015 By Susan Haigney BioPharm International Volume 28, Iss…

Article Continuous Chromatography: Trends, Definitions and Approaches
Process Development Forum speaks with Karol Lacki, Customer Collaborations Leader at Cytiva, about continuous chromatography. There is a lot of attention being paid to continuous chromat…

Article Re-use of Protein A Resin: Fouling and Economics
Mar 01, 2015 By Anurag S. Rathore, Mili Pathak, Guijun Ma, Daniel G. Bracewell BioPharm International Volume 3, Issue 28 In the past two decades, Protein A affinity chromatography ha…

Article Continuous Manufacturing: A Changing Processing Paradigm
Apr 01, 2015 By Randi Hernandez BioPharm International Volume 28, Issue 4 Although continuous manufacturing is well established for bulk chemicals, complex automation and validation …

Article SEC in the Modern Downstream Purification Process
Mar 01, 2015 By R. Christopher Manzari, J. Kevin O'Donnell BioPharm International Volume 3, Issue 28 Since the introduction of commercial chromatography resins approximately six de…

Article Finding Opportunities in Brazil
Feb 06, 2015 By Hellen Berger BioPharm International Volume 28, Issue 2 Brazil’s turbulent presidential election in October 2014 shed some light on the country’s political landscape …

Article The Bullish Outlook for Biosimilars
Feb 01, 2015 By Jill E. Sackman, PhD, Michael J. Kuchenreuther, PhD BioPharm International There are several important reasons for stakeholders to be optimistic about prospects for b…

Article Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
The authors review efforts to limit polymer degradation without significantly impeding cell growth. Jan 01, 2015 By Sara Ullsten, Shujian Yi, Jeffrey Carter, Eva Lindskog, Pokon Ganguli, Her…

Article Ligand-Binding Assays and the Determination of Biosimilarity
During biosimilar development, it is necessary to demonstrate that the physicochemical properties, efficacy, and safety (e.g., immunogenicity) of the biosimilar are similar to those of the …

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