Search results for " biopharmaceuticals"
Article
Selecting the Right Viral Clearance Technology
“While traditionally viral clearance has been achieved during the downstream processing of biopharmaceuticals, increasingly there is a focus on ensuring that raw materials are free of adventitious age…
Article
Use of Multivariate Data Analysis in Bioprocessing
Apr 06, 2015
By Anurag S. Rathore, Sumit K. Singh
BioPharm International
The ever increasing demand of biotherapeutics, together with the pressure to contain healthcare costs have motiva…
Article
SEC in the Modern Downstream Purification Process
Mar 01, 2015
By R. Christopher Manzari, J. Kevin O'Donnell
BioPharm International
Volume 3, Issue 28
Since the introduction of commercial chromatography resins approximately six de…
Article
Fermentation for the Future
Jan 01, 2015
By Cynthia Challener, PhD
Microorganisms—bacteria and yeast—have been widely used for the production of genetically engineered (recombinant) biopharmaceuticals. Typical examples…
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
Identifying CQAs for a biotech therapeutic is the first and arguably the most difficult step in implementation of quality by design (QbD) for development and production of biopharmaceuticals (3, 4). …
Article
Bureaucratic Roadblocks Threaten Biopharma Growth
This is particularly true in knowledge-intensive sectors such as biopharmaceuticals.
The good news is that some mature and emerging economies are making growing use of patent systems to facilita…
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Trends in Downstream Bioprocessing
Downstream processing involves the recovery and purification of protein therapeutics for biopharmaceuticals, vaccines, and other biologics. It involves the removal of insoluble cell debris and parti…
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Regulatory Challenges in the QbD Paradigm
The authors demonstrate how an integrated model is helping to achieve regulatory flexibility. This article is part of a special section on biopharmaceutical trends.
With the dawn of the 2…
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
In Quality by Design for Biopharmaceuticals: Principles and Case Studies, A.S. Rathore and R Mhatre eds. (John Wiley & Sons, Inc., Hoboken, New Jersey, 2009) pp 9-27.
53. FDA, Notice of pilot prog…
Article
Using Digital Twins to Model Process Chromatography
Mechanistic models provide process understanding for developing robust manufacturing processes and for scale up and tech transfer.
By Jennifer Markarian
A digital twin is a model of a proces…