Search results for " Mabs" in Articles / App Notes
Article
Innovative Chromatography Resins Can Improve Purity and Quality
Ongoing downstream challenges
Constraints still remain in downstream processing of mAbs, which continue to be the most successful segment of biological molecules in the market in terms of required…
Article
Single-Use for Downstream Chromatography: Benefit or Hindrance?
Single-use technology is gaining ground in downstream bioprocessing, but challenges stall further adoption.
By Feliza Mirasol
ARTMOIS/STOCK.ADOBE.COM
Biopharmaceutical manufactu…
Article
Challenges in Cell Harvesting Prompt Enhancements
al, “Recovery and Purification Process Development for Monoclonal Antibody Production,” MAbs online, DOI: 10.4161/mabs.2.5.12645, Sept. 1, 2010.
Article
Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
As of February 2017, FDA lists 68 approved mAbs, and approvals have been increasing each year since the late 1990s (3). mAbs are comprised of several domains that contribute to their function. The Fab…
Article
Ligand-Binding Assays and the Determination of Biosimilarity
In addition, for mAbs, ligand-binding assays do provide a valuable assessment of biosimilarity and should be included, orthogonally, with cell-based functionality assessments.
Just one part of the…
Article
Single-Domain Antibodies for Brain Targeting
Conclusion
After a decade of intensive engineering followed by preclinical and clinical testing, antibody fragments joined mAbs as powerful therapeutic agents particularly for targeting cancer, in…
Article
Digitalization: The Route to Biopharma 4.0
AI-ML Applications In Bioprocessing: ML as an Enabler of Real Time Quality Prediction in Continuous Manufacturing of Mabs. Computers & Chemical Engineering 2022, 164,107896. DOI: 10.1016/j.compchemeng…
Article
As the therapeutic pipeline diversifies, chromatography toolboxes are expanding.
For traditional mAbs, protein A chromatography is used to capture antibodies. Depending on the structure of the target antibody and the impurity profile, other affinities, like protein L or variants o…
Article
Top Process Development Trends for 2021 and a Look into 2022
The COVID-19 pandemic continues to shape bioprocess development trends, and many lessons have been learned from industry’s response to and preparedness for dealing with a public health crisis. Howev…
Article
Updating Viral Clearance for New Biologic Modalities
Guidance is needed
Compounding all these challenges is the fact that published regulatory guidances have been based on traditional biologics, such as mAbs and related Protein A binders, says Berri…