Search results for " preparative" in Articles / App Notes

Article Preclinical Evaluation of Product Related Impurities and Variants
First, a downstream process is created for separating these species at the preparative scale. The selection of resin, as is known, is guided by the physicochemical properties of the mAb product under …

Article Viral Clearance Challenges in Bioprocessing
Challenges remain for virus removal and validation. Nov 1, 2014 By: Cynthia Challener, PhD BioPharm International Volume 11, Issue 27, pp. 42-44 Removal and inactivation of adventitio…

Article Monitoring and Control of Inline Dilution Processes
Buffer management has received less attention in process intensification despite the high costs and labor-, space-, time-, and material-intensive nature of this common downstream activity. By…

Article N-Glycan Analysis of Biotherapeutic Proteins
This article summarizes the approaches, challenges, and future perspectives for the characterization of N-glycans in biopharmaceutical products. By Aled Jones Protein glycosylation, the addi…

Article Using Quality by Design to Develop Robust Chromatographic Methods
Quality-by-design principles can be used to understand chromatographic measurement system variability. Sep 2, 2014 By: Melissa Hanna-Brown, Kimber Barnett, Brent Harrington, Tim Graul, Jim…

Article The Importance of Process Intensification and PAT for Achieving Real-Time Release
Creativity and collaboration are required to overcome complex method development challenges. By Kelvin H. Lee and Mark Lies …

Article Improving mAb Manufacturing Productivity by Optimizing Buffer and Media Prep Process Flow
Innovative approaches, including ready-to-use materials and in-line dilution, can significantly streamline overall bioprocessing operations.   By: Pranav Vengsarkar and Nandu Deorkar I…

Article From Darwin to Recombinant Fc Multimers
Topics from a Darwinistic viewpoint on how business models are evolving in the Life Science industry to breakthrough research data from Momenta Pharmaceuticals on a recombinant trivalent Fc protein …

Article Continued Process Verification for Biopharma Manufacturing
The authors discuss complications of implementing continued process verification and provide recommended approaches. Oct 1, 2014 By: Jeff Fleming, Robin Payne BioPharm International …

Article Design of Experiments for Analytical Method Development and Validation
Design of experiment is a powerful development tool for method characterization and method validation. Design of experiments (DOE) is a well-proven characterization approach within product…

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