Search results for " information"
Article
Cleaning of Dedicated Equipment: Why Validation is Needed
It aims at harmonizing inspection procedures globally by developing common GMP standards, training inspectors, and facilitating exchange of information and mutual confidence between regulators.
Article
ÄKTA Laboratory-Scale Chromatography Systems Handbook
Experienced system users will also find valuable and detailed information on different hardware modules.
Download now.
Article
A Bright Future for the Plasma Fractionation Industry
The advantages of this QbD approach were claimed to be better information for process design, clear justification of the process and product specifications, and well-structured process and product kno…
Article
Biosimilars Will Bring Significant Litigation and Patent Challenges
…he litigation to date has stemmed from biosimilar applicants trying to avoid the BPCIA's complicated information exchange and negotiation processes, and attempting to side-step its requirements to di…
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Ensuring the Quality of Biologicals
This informational chapter, which is intended to be published by the end of 2015, has undergone public enquiry and gives examples of the critical quality attributes specific to each class of raw mater…
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Modular Manufacturing Platforms for Biologics
Thus, the company writes, a measure of both viable and nonviable particles is required to provide enough information about whether or not a cleanroom is suitable for a biologic (12).
The level of …
Article
Continuous Manufacturing: A Changing Processing Paradigm
Apr 01, 2015
By Randi Hernandez
BioPharm International
Volume 28, Issue 4
Although continuous manufacturing is well established for bulk chemicals, complex automation and validation …
Article
Handbook: Size Exclusion Chromatography Principles and Methods
This handbook describes the use of SEC for the purification and separation of biomolecules, with a focus on practical information for obtaining the best results. The media available, selection crite…
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FDA Approves First Biosimilar
The data on Zarxio submitted to FDA included information on structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data…
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The Bullish Outlook for Biosimilars
Just this information is enough to warrant a bullish sense of optimism, not only for the innovator biologics market, but for biosimilars as well.
Now consider a looming patent cliff for many of …