Search results for " 2015"
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
USP Publishes Monoclonal Antibody Guidelines
Mar 02, 2015
By Dale Schmidt, M.S., Anita Y. Szajek, PhD, Fouad Atouf, PhD, Tina S. Morris, PhD
BioPharm International
Volume 3, Issue 28
As FDA gears up towards approving biosimilar dru…
Article
Tackling Analytical Method Development for ADCs
Challener, " Tackling Analytical Method Development for ADCs," BioPharm International 28 (2) 2015.
Article
SEC in the Modern Downstream Purification Process
Kevin O'Donnell, “SEC in the Modern Downstream Purification Process,” BioPharm International 28 (3) 2015.
Article
Quality by Design and Extractable and Leachable Testing
Feb 01, 2015
By Anthony Grilli
BioPharm International
Biopharmaceutical packaging performs several vital functions in assuring the drug product safety. First and foremost, packaging must b…
Article
Fermentation for the Future
Jan 01, 2015
By Cynthia Challener, PhD
Microorganisms—bacteria and yeast—have been widely used for the production of genetically engineered (recombinant) biopharmaceuticals. Typical examples…
Article
Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
Jan 01, 2015
By Sara Ullsten, Shujian Yi, Jeffrey Carter, Eva Lindskog, Pokon Ganguli, Hernan Parma, Eva Blanck
This article discusses efforts to limit polymer degradation without significant…
Article
Healthcare Reform in China
In fact, it is poised to become the second largest market in 2015 given that its annual growth rate of sales is between 15 and 20%, according to Yanzhong Huang, a senior fellow of global health at the…
Article
Methods Accelerate Biosimilar Analysis
Methods Accelerate Biosimilar Analysis
Effective application of mass-spectrometry tools can optimize biosimilar analysis, reducing development time and cost.
By Mario DiPaola, …
Article
Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
While the multiple attributes method gains ground and traditional lab methods improve, broad efforts are underway to determine biopharmaceuticals’ most significant critical quality attributes and en…