Search results for " Europe" in Articles / App Notes
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Testing product and process intermediates alone is helpful, but does not provide a complete solution to viral safety. This article proposes integrated solutions for systemic and proactive viral risk m…
Article
Optimizing Cation-Exchange Chromatography with High-Throughput Process Development for mAb Purification
Since the first therapeutic antibody came onto the market in 1986, up to the end of 2014, 47 products have been approved in the United States or Europe for a number of diseases including various types…
Article
Breakthrough Drugs Raise Development and Production Challenges
The time reduction presents “significant challenges to the development team,” he commented, and may be further complicated if the firm seeks to file simultaneous applications in Europe, Japan, and eme…
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Taking a “Development-by-Design” Approach to Cell Therapies
Invetech has been working on cell therapy process scale-up automation for more than 10 years and has successfully completed projects in North America, Europe, and Asia for companies that include Argos…
Article
Biopharma Advances Demand Specialized Expertise
Roundtable participants are Gary Chambers, business manager biopharma labs, Europe, SGS; Bill Hartzel, director of strategic execution, Catalent Pharma Solutions; Chris R. Lively, PhD, director of bio…
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 …