Search results for " monoclonal" in Articles / App Notes
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
By Mark Plavsic
Use of continuous cell lines in the manufacture of biological therapeutic products, such as vaccines, recombinant proteins, and monoclonal antibodies, is associated with the concom…
Article
mAbs to Watch in 2016
By Randi Hernandez
Of the 45 new molecular entities and new therapeutic biological products approved by FDA in 2015, nine products were monoclonal antibodies (mAbs). And there may be many more o…
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Ligand-Binding Assays and the Determination of Biosimilarity
For monoclonal antibodies (mAbs), which make up a large portion of the biosimilars currently under development, it is important to remember that the different ends of the molecule are involved in bind…
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Challenges and Trends in Biopharma Facility Design
We have designed a turnkey modular factory, KUBio, which offers a monoclonal antibody manufacturing factory within 14-18 months and is pre-designed to support achieving cGMP requirements.
For biop…
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Challenges in Analytical Method Development and Validation
While the biopharmaceutical industry has had success in reducing risk by incorporating analytical platform technologies for monoclonal antibody products, new molecules and drug conjugates pose additio…
Article
Trends in BioPharma Approvals in 2013
In 2013, 20 products containing new biopharmaceutical molecular entities (defined herein as recombinant proteins, monoclonal antibody or biosynthesized nucleic acid-based products) were approved in t…
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Optimizing KiH bispecific antibody chromatography steps
However, due to their increased complexity bsAbs often have higher levels of impurities in comparison to monoclonal antibodies (mAbs). This presents challenges to downstream processing.
This web a…
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Evaluating the Use of Continuous Chromatography
Progression of Continuous Downstream Processing of Monoclonal Antibodies: Current Trends and Challenges. Biotechnology and Bioengineering 2018, 115 (12), 2893–2907. DOI: 10.1002/bit.26812
3. …
Article
Advances in Sterilization Technologies for Overcoming Viral-Vector Manufacturing Challenges
Chromatography systems have presented challenges as well, as most were developed for monoclonal antibody processes with starting volumes of 1000 L. Suppliers are, Langhauser observes, working to addre…
Article
Webinar: Intensifying downstream bioprocessing with continuous technologies
In this webinar we will explore common bottlenecks in downstream processing and look at continuous processing solutions that can further intensify the monoclonal antibody (mAb) platform.
We will di…