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…