Search results for " monoclonal"

Article Development of Purification for Challenging Fc-Fusion Proteins
In response, titers for monoclonal antibodies (mAbs) and Fc-fusion proteins have significantly increased (1-5). Particularly for Fc-fusion proteins, these improvements have resulted in a …

Article Patenting Prospects for Cell-Based Therapies
For example, in the Federal Circuit decision, In re Alonso (11), the claimed invention was directed to antibody reagents and methods for treating neurofibrosarcomas using a monoclonal antibody idiotyp…

Article N-Glycan Analysis of Biotherapeutic Proteins
More than half of all biotherapeutics are glycosylated (2), including monoclonal antibodies (mAbs), Fc-fusion proteins, clotting factors, and cytokines such as erythropoietin. Of these, mAbs represent…

Article Single-use Bioreactors Have Reached the Big Time
“[Cytiva] is taking its experience in single-use bioreactor technologies for monoclonal antibody, recombinant protein, and vaccine processes and applying it in our Xuri line of cell therapy equipment …

Article Improving Process-Scale Chromatography
The development of new resin chemistries including enhancements to Protein A for monoclonal antibody (mAb) capture, increasing use of automation, implementation of single-use technologies, and explora…

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…

Poster Optimizing dynamic binding capacity and aggregate clearance in an mAb polishing step
Capto™ S ImpAct is a strong cation exchange (CIEX) chromatography medium (resin) designed for monoclonal antibody (MAb) polishing steps. In this study, optimization of binding conditions targeting h…

Article 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…

Article 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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