Search results for " Global Use of Medicines"

Article Ensuring Viral Safety of Viral Vaccines and Vectors
Ensuring Viral Safety of Viral Vaccines and Vectors Viral vaccines and viral vectors used in biotherapeutic applications carry the risk of microbial contamination, which must be addressed. …

Article Cleaning of Dedicated Equipment: Why Validation is Needed
This article discusses cleaning validation of equipment dedicated to the production of a single API. By Cristina Baccarelli, Paola Bernard, Teresa Cortellino, Oscar Cruciani, Rita Pacello, Chi…

Article The Bullish Outlook for Biosimilars
Feb 01, 2015 By Jill E. Sackman, PhD, Michael J. Kuchenreuther, PhD BioPharm International There are several important reasons for stakeholders to be optimistic about prospects for b…

Article Application of Quality by Design to Viral Safety
A quality-by-design approach defines a range of potential viral contaminants of source materials and can be used to effectively achieve viral clearance. Oct 1, 2014 BioPharm International …

Article Remote Monitoring and Big Data Advance Upstream Automation
Connected, integrated bioprocessing enterprises with greater data analytics capabilities are coming. By Cynthia A. Challener As upstream processing drives toward higher efficiencies in meeti…

Article Strategizing for Rapid Changeovers in Biologics Manufacturing
Olivier Le Moal/Stock.Adobe.com By Cynthia A. Challener  Facility and equipment design are important, but the team and its experience matter most. Through its Operation Warp Speed pro…

Article Labeling of Biosimilars
EMA is under pressure to exert even tighter standards on biosimilars being marketed in Europe. Feb 01, 2015 By Sean Milmo BioPharm International The European Medicines Agency (EMA) has r…

Article Challenges and Trends in Biopharma Facility Design
Experts discuss the future of modular manufacturing and the challenges that biopharma manufacturers face in facility design. Sep 1, 2014 By: Susan Haigney BioPharm International Volu…

Article Drugs, At What Cost?
In a new report, The Global Use of Medicines: Outlook through 2017, IMS Institute for Healthcare Informatics projects that in 2014 total global spending on medicines will, for the first time, exceed $…

Article FDA Framework Spurs Advanced Therapies
Greater clarity on the application of existing regulations will accelerate development of cell and gene therapies. By Cynthia A. Challener Ibreakstock/Shutterstock.co…

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