Search results for " Europe"
Article
Re-use of Protein A Resin: Fouling and Economics
30-40; Pharmaceutical Technology Europe, March (2003), pp. 45-56.
21. J. Moscariello, E. Lightfoot, and A. S. Rathore, BioPharm International 18 (8) (2005).
22. A. S. Rathore, S. Mittal, S. Lu…
Article
Vaccine Development and Production Challenges Manufacturers
In 2014, GSK filed for approval of its RTS,S vaccine by the European Medicines Agency (EMA) under an EMA assessment process that could support a recommendation by the World Health Organization for mar…
Article
FDA Approves First Biosimilar
Mar 06, 2015
By Randi Hernandez
BioPharm International
FDA approved Sandoz’s Zarxio (filgrastim-sndz) on March 6, 2015. The approval is a groundbreaking decision, as Sandoz is the firs…
Article
Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
Chemical analyses
Chemical analyses were performed by Toxikon Europe N.V. in Leuven, Belgium. Extraction of solid materials (containers, films, and resins) was done by refluxing the material in di…
Article
A Q&A With Dr. Anurag Rathore About the Future of QbD, Part 2
FDA, major manufacturers based in North America are the furthest along in QbD implementation followed by the major manufacturers based in Europe. These are followed by the mid-size companies based in …
Article
Biopharma Manufacturers Respond to Ebola Crisis
Demand for new therapies and vaccines spotlights production challenges.
Oct 1, 2014
By: Jill Wechsler
BioPharm International
Volume 27, Issue 10, pp. 8-9
The development of new tr…
Article
A Q&A With Dr. Anurag Rathore About the Future of QbD, Part I
Even biosimilar manufacturers based outside North America and Europe are also implementing QbD. But every company is in the process of trying to figure out better (as in more efficient with respect to…
Article
Pharma Investments Reflect Key Industry Trends
In Europe, Merck Serono is spending $68 to $69 million (€50 million) to modernize its fill-finish plant in Bari, Italy. Merck’s Allergopharma unit, meanwhile, is constructing a $55 million (€40 millio…
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
Reason is UK business manager, Life Science Services, Group Manager SGS M-Scan Europe.
Article
Q&A with Eric Langer, about the evolution of the role of CMO’s in Bioprocessing
In Europe, 53% of decision makers see a shrinking talent pool as an on-going problem.
CMO’s are seen increasingly as valuable partners because they work on a wide variety of projects, so their t…