Search results for " monoclonal"
Article
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…
Article
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…
Article
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. …
Webcast
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…
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…
Article
Purification strategies for antibody-derived entities: bispecifics and fragments
Purification platforms used for many monoclonal antibodies (mAbs) need to be adopted for antibody variants to simplify protocols and improve purity and yield. The safety and efficiency requirement of …
Article
Guide for selecting affinity resins for mAbs, bsAbs, and antibody fragments
The selector chooses based on the structure of your monoclonal antibody, bispecific antibody, or antibody fragment and the impurity profile.
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Article
A Closer Look at Affinity Ligands
Large-scale manufacturing of a therapeutic monoclonal antibody (mAb) starts with the expression of the antibody in mammalian cells, typically CHO [Chinese hamster ovary] cells, followed by a series of…