Search results for "antibodies"
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
has established general monographs that cover common quality attributes and that are applicable to a specific class of biologicals such as monoclonal antibodies (mAbs), rDNA products, or vaccines for …
Article
Modular Manufacturing Platforms for Biologics
By using modularization and the other aforementioned technologies such as continuous manufacturing, facilities to produce monoclonal antibodies (mAbs) can also be operational 12 months after project i…
Article
Modern Manufacturing Systems Key to FDA Quality Initiative
This structure replaces specific divisions for monoclonal antibodies and for other proteins staffed by more specialized reviewers. The change should help OBP manage its workload more effectively as bi…
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
Improving PAT for Biologics
The complexity of biopharma processes requires innovative solutions.
Dec 01, 2014
By Cynthia Challener, PhD
BioPharm International
A key component of the quality-by-design (QbD) ap…
Article
Viral Clearance Challenges in Bioprocessing
“This practice is not in full compliance with current guidelines, but some agencies have accepted this type of data for IND applications of mAbs [monoclonal antibodies] derived from CHO [Chinese hamst…
Article
Setting Standards for Biotech Therapeutics in India
Many new general chapters pertaining to topics such as therapeutic monoclonal antibodies, host cell proteins and DNA, and viral safety are in the works for the next IP edition.
As mentioned previo…
Article
Continued Process Verification for Biopharma Manufacturing
The authors discuss complications of implementing continued process verification and provide recommended approaches.
Oct 1, 2014
By: Jeff Fleming, Robin Payne
BioPharm International
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Article
Application of Quality by Design to Viral Safety
A quality-by-design approach defines a range of potential viral contaminants of source materials and can be used to effectively achieve viral clearance.
Oct 1, 2014
BioPharm International
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