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Article Affinity chromatography Handbook - Vol. 3: Specific Groups of Biomolecules
Affinity chromatography (AC) separates proteins on the basis of a reversible interaction between a protein (or group of proteins) and a specific ligand coupled to a chromatography matrix. The techni…

Article Biosimilars: Making the Switch Comes with Challenges
The focus would be comparisons of in-vitro studies to characterize extensively the functions and activity of the molecule. “[This approach] is usually more sensitive in detecting differences than in v…

Article An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Testing product and process intermediates alone is helpful, but does not provide a complete solution to viral safety. This article proposes integrated solutions for systemic and proactive viral risk m…

Article A Q&A on Bioprocessing Trends and Technologies at INTERPHEX 2016
Bioprocessing equipment and materials, as well as technical discussions about process development, were in prominent positions at the INTERPHEX 2016 trade show, held in New York in late April. Rita …

Article Innovative Therapies Require Modern Manufacturing Systems
FDA and industry see progress and challenges in bringing cutting-edge medicines to patients. By Jill Wechsler FDA set a 19-year record in 2015 in approving more new drugs and biologics, and …

Article Going Small to Achieve Success on the Commercial Scale
Scale-down modeling is instrumental in supporting the development of downstream biopharma manufacturing processes. By Cynthia A. Challener Biopharmaceutical manufacturing involves a series o…

Article Biopharma in 2015: A Year for Approvals and Innovations
Insiders agree that 2015 was a banner year for biopharma. Last year’s new drug approvals reached 51, besting every year since 1950. Twenty approvals (39%) went to biological drugs—up from 35% in 201…

Article A Q&A With Günter Jagschies: Recovery of Biological Products Conference Series
Process Development Forum speaks with Günter Jagschies, Cytiva, who is sitting on the organizing committee for the Recovery of Biological Products XVII Conference, which will take place June 19-24, …

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 Robust Optimization, Simulation, and Effective Design Space
Jul 01, 2015 By Thomas A. Little, PhD BioPharm International Volume 28, Issue 7, pg 40–44 Approaches to the generation of process models, optimization techniques, and application of …

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