Search results for " monoclonal" in Articles / App Notes
Article
Best Practices in Qualification of Single-Use Systems
Figure 1 depicts a typical monoclonal antibody (mAb) drug manufacturing process. Single-use bioreactors are widely used in cell line expansion, and the use at production scale is increasing, notably i…
Article
Ensuring the Quality of Biologicals
has established general monographs that cover common quality attributes and that are applicable to a specific class of biologicals such as monoclonal antibodies (mAbs), rDNA products, or vaccines for …
Article
Modular Manufacturing Platforms for Biologics
By using modularization and the other aforementioned technologies such as continuous manufacturing, facilities to produce monoclonal antibodies (mAbs) can also be operational 12 months after project i…
Article
Modern Manufacturing Systems Key to FDA Quality Initiative
This structure replaces specific divisions for monoclonal antibodies and for other proteins staffed by more specialized reviewers. The change should help OBP manage its workload more effectively as bi…
Article
Continuous Manufacturing: A Changing Processing Paradigm
Apr 01, 2015
By Randi Hernandez
BioPharm International
Volume 28, Issue 4
Although continuous manufacturing is well established for bulk chemicals, complex automation and validation …
Article
Tackling Analytical Method Development for ADCs
Capillary isoelectric focusing (cIEF), such as imaged cIEF, has been a reasonable substitute, but experience with monoclonal antibodies (mAbs) suggests that there may be differences in the information…
Article
SEC in the Modern Downstream Purification Process
While SEC may have mostly been abandoned in monoclonal antibody (mAb) and other protein purifications, it is still commonly used in the purification of viruses and plasmids.
SEC, also known as gel…
Article
Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
In this study, the monoclonal antibody-expressing CHO DG44 cell line was used under license from Cellca GmbH, Laupheim, Germany.
Chemical analyses
Chemical analyses were performed by Toxikon E…
Article
Improving PAT for Biologics
The complexity of biopharma processes requires innovative solutions.
Dec 01, 2014
By Cynthia Challener, PhD
BioPharm International
A key component of the quality-by-design (QbD) ap…
Article
Optimizing Resin Performance with Disposable Chromatography Solutions
Tingley (Repligen): Resin structure is central to separation success, especially with more complex proteins such as monoclonal antibodies. OPUS was designed to allow biopharmaceutical manufacturers to…