Search results for " comparability" in Articles / App Notes

Article Framing Biopharma Success in 2016
Corporate restructurings, regulatory initiatives, and biosimilars will shape biopharma development in 2016. By Rita C. Peters The US biopharmaceutical industry turned a new page in 2015 when…

Article Automated harvesting and 2-step purification of unclarified mammalian cell-culture broths containing antibodies
Therapeutic monoclonal antibodies represent one of the fastest growing segments in the pharmaceutical market. The growth of the segment has necessitated development of new efficient and cost saving …

Article Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific Reproducibility
By Leonard P. Freedman, Mark C. Gibson, Richard M. Neve Irreproducible preclinical research is a global, expensive, and well-recognized problem that contributes to delays and increased costs of …

Article E. coli growth and Dab expression in single-use and stainless steel fermentors
This application note describes the performance of the Xcellerex™ single-use XDR-50 MO stirred-tank fermentor in an E. coli domain antibody (Dab) production process  developed for a stainless steel …

Article A Q&A With Prof. Alois Jungbauer: The Role of HIC in Biotech
Process Development Forum speaks with Professor Alois Jungbauer, Department of Biotechnology, BOKU, Vienna, about Hydrophobic Interaction Chromatography (HIC). What is your view of HIC in the bi…

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 …

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