Search results for " monoclonal"
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…
Article
Viral Clearance Challenges in Bioprocessing
Challenges remain for virus removal and validation.
Nov 1, 2014
By: Cynthia Challener, PhD
BioPharm International
Volume 11, Issue 27, pp. 42-44
Removal and inactivation of adventitio…
Article
High-Throughput Process Development in an Historical Environment
…gh throughput techniques and different formats were used to identify the effect of ligand density in monoclonal antibody (mAb) purifications. Two different novel multimodal polishing Capto™ ImpRes re…
Article
Setting Standards for Biotech Therapeutics in India
Many new general chapters pertaining to topics such as therapeutic monoclonal antibodies, host cell proteins and DNA, and viral safety are in the works for the next IP edition.
As mentioned previo…
Article
Biopharma Manufacturers Respond to Ebola Crisis
Most discussed is the ZMapp cocktail of three monoclonal antibodies from Mapp Biopharmaceutical of San Diego, which made headlines when two American health workers infected by Ebola recovered followin…