Search results for "analytical"
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
Platform Approach Speeds Process Development
A modular cell-culture platform demonstrates accelerated process development.
By Harald Bradl, Jan Bechmann, Benedikt Greulich, Markus Michael Mueller, Patrick Schulz, Thomas Wucherpfennig
C…
Article
A Q&A With Jeff Carter on Trends in Single-Use Technologies
What general trends do you see in single-use technologies within the biopharmaceutical industry?
We are now seeing standardization of materials testing data and corresponding analytical techniques…
Article
Innovative Therapies Require Modern Manufacturing Systems
FDA and industry see progress and challenges in bringing cutting-edge medicines to patients.
By Jill Wechsler
FDA set a 19-year record in 2015 in approving more new drugs and biologics, and …
Article
Biacore Concentration and Ligand-Binding Analyses
During development and in quality control, a range of analytical technologies are used to characterize biotherapeutic drugs in terms of their structural integrity and activity. In this white
paper, …
Article
CMOs Continue to Improve Overall Biomanufacturing Performance
These range from better analytical testing and product release services to better operations staff training, optimized media and improved existing quality management systems. Better process developmen…
Article
Robust Optimization, Simulation, and Effective Design Space
The residual variation is the root mean squared error (RMSE) from the model and includes the variation from the analytical method as well as any other uncontrolled factor when building the model.
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Article
Taking a “Development-by-Design” Approach to Cell Therapies
A new CEO, David Mazzo, with a doctorate in analytical chemistry and experience running both private and public international biopharma companies, assumed NeoStem’s leadership in January. He sees no c…
Article
Quality Systems Key to Lifecycle Drug Management
In most situations it’s easier to design a new drug than to update existing analytical methods and technology, noted Ganapathy Mohan, head of global CMC at Merck, Sharp and Dohme. Global approval of a…
Article
Biosimilars Will Bring Significant Litigation and Patent Challenges
May 04, 2015
By Randi Hernandez
The risks involved with patent suits may become a bit more undesirable, thanks to new legislation aimed at deterring unreasonable patent suits. A senate bill…