Search results for " future"
Article
Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
In general, when risk ranking is performed for a particular manufacturing site, microbial failure events are only infrequently observed, and similar, future events are difficult to predict. It is chal…
Article
Biopharma Advances Demand Specialized Expertise
Jun 15, 2015
By BioPharm International Editors
BioPharm International eBooks
Volume 28, Issue 13
Contract service providers share insights on biopharma market developments and the impl…
Article
What’s In a Name? For Biosimilars, A Lot
This determination may ultimately factor into future FDA policy or guidance documents on biosimilar naming. While FDA and USP work closely on nomenclature policy, “USP naming is not directly implicate…
Article
Advanced Technologies Facilitate Scale-up and Technology Transfer
Advances in single-use technologies designed specifically for microbial systems may, however, lead to their greater use in the future.
Galliher agrees that single-use technologies are not a panace…
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Use of Multivariate Data Analysis in Bioprocessing
The authors see great scope for further refinements and improvements in MVDA modeling approaches to widen its applicability towards analysis of structured datasets, and perhaps in the future, for unst…
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…
Article
Ensuring the Quality of Biologicals
acknowledges that there are number of challenges to address in the future development of individual monographs for biologicals. First, there is a need for flexibility within biological monographs beca…
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Modular Manufacturing Platforms for Biologics
Therapeutic treatments produced via a modular vaccine suite—a pandemic-ready modular facility—could be a good option in the future when dealing with the proliferation of tropical diseases and regional…
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Continuous Chromatography: Trends, Definitions and Approaches
One can envision that future process control will be based on algorithms that will operate the process in a state where a product’s CQAs are not affected and that the process is operated at its curren…
Article
Vaccine Development and Production Challenges Manufacturers
But the plant’s future is murky following Novartis’ divestiture of most of its vaccine business to GSK and its flu vaccine program to Australia’s CSL.
A House Energy & Commerce subcommittee held a …