Search results for " Biopharm"
Article
Quality Systems Key to Lifecycle Drug Management
FDA officials plan to try again to offer regulatory relief in filing supplements and also in undergoing plant inspections for those biopharma companies that implement QbD and advanced manufacturing te…
Article
Host-Cell Protein Measurement and Control
Shameem, “Host-Cell Protein Measurement and Control” BioPharm International 28 (6) 2015.
Article
Advanced Technologies Facilitate Scale-up and Technology Transfer
Challener
BioPharm International
Volume 28, Issue 6, pg 20-23
It is hard to believe, but the biopharmaceutical industry is already old enough to have aging facilities that are decades ol…
Article
Biomanufacturing Outsourcing Globalization Continues
…nd Europe, according to preliminary data from BioPlan Associates’ 12th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production (1).
As part of the survey, biotherapeut…
Article
Optimization of Protein Expression in Escherichia Coli
May 01, 2015
By Siavash Bashiri, David Vikström, Nurzian Ismail
BioPharm International
Volume 28, Issue 5
Production of proteins for manufacturing therapeutics and pharmaceuticals is a c…
Article
Drug Discovery and Development in India
In addition, venture capital and private equity have not been actively supporting such biopharmaceutical start-ups, leaving such companies to turn towards larger multinational pharmaceutical companies…
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
Finding Opportunities in Brazil
Berger, "Finding Opportunities in Brazil," BioPharm International 28 (2) 2015.
Article
The Bullish Outlook for Biosimilars
Stanton, “AstraZeneca shutting asthma drug plant as pipeline shifts to biologics,” BioPharmaReport, www.biopharma-reporter.com/Markets-Regulations/AstraZeneca-shutting-asthma-drug-plant-as-pipeline-sh…
Article
Quality by Design and Extractable and Leachable Testing
Grilli, "Quality by Design and Extractable and Leachable Testing," BioPharm International 28 (2) 2015.