Search results for " monoclonal" in Articles / App Notes
Article
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
Points to consider in the manufacture and testing of monoclonal antibody products for human use. Rockville, MD; 1997.
5. Schnerman MA, Sunday BR, Kozlowski S, Webber K, Gazzano-Santoro H, Mire-Slu…
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
Biotech therapeutics, particularly complex products such as monoclonal antibodies (mAbs), can have numerous quality attributes that can potentially impact safety and/or efficacy of the product (2). Id…
Article
USP Publishes Monoclonal Antibody Guidelines
USP standards for mAbs
Currently, licensed monoclonal antibody (mAb) therapeutics include those involved in the activation of effector cells, cell killing, cross-linked induced apoptosis, antagonis…
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Evolution of the Monoclonal Antibody Purification Platform
Traditional Monoclonal Antibody Platform
Figure 1 illustrates the traditional mAb platform that is commonly used (2,3). Typical steps include:
• Protein A chromatography for capture of…
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Comparing Protein A Resins for Monoclonal Antibody Purification
With greater economic pressure on monoclonal antibody (mAb) production for therapeutic and research uses, antibody titers in mammalian cell culture have increased dramatically over the past 20 years. …
Article
Late stage failures of monoclonal antibodies
In this article, the authors showcase some of the monoclonal antibody (mAb) candidates that reached Phase III clinical trials but were discontinued at later stages.
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Impact of Media Components on CQAs of Monoclonal Antibodies
The authors review how media components modulate the quality of monoclonal antibody products.
By Anurag Rathore, Rajinder Kaur, Dipankar Borgayari
Recombinant protein products have…
Article
Monoclonal Antibodies Key to Unlocking the Biosimilars Market
This growth in large part is due to the fact that numerous monoclonal antibody (mAb) biosimilars are expected to be launched in the next few years as patents on key drugs, such as infliximab (Remicade…
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The Development and Application of a Monoclonal Antibody Purification Platform
The following article describes the development of a purification platform for monoclonal antibodies (MAbs) at Pfizer's Global Biologics division, including how the individual unit operations have bee…
Article
High-concentration monoclonal antibody drugs: manufacturing challenges
The growth in the formulation of drugs suitable for delivery by subcutaneous (Sub-C) injection highlights manufacturing challenges associated with the higher concentration of active ingredient…