Search results for "Resin lifetime"
Article
Sanitization Opportunities for Protein A Resins
… purification—MabSelect PrismA—with 30 mM PAA combined with NaOH cleaning-in-place regimen in a resin lifetime study.
Article
Efficient Cleaning-In-Place Methods for Protein-Based Antibody Affinity Chromatography Resins
Various cleaning strategies and the impact of different cleaning agents and concentrations on the resin lifetime are presented. As the use of sodium hydroxide (NaOH) is considered standard in the biop…
Article
A Closer Look at Affinity Ligands
This reduces the resin lifetime and introduces a process related impurity into the product mainstream. Leached protein A is considered a CQA (critical quality attribute) to measure for with a release …
Article
Evaluation of Fibro PrismA for Scalable Single-Use mAb Purification
However, because clinical batch sizes are small, fewer cycles are required compared with full-scale manufacturing; this means that the full resin lifetime is rarely realized.
Bayer worked with Cyt…
Article
Next Generation Process Chromatography
Chromatography is an essential part in the production of all biopharmaceuticals. Without it the industry would not be able to produce therapeutics in an economic manner. This is true for monoclonal …
Article
Regulatory Challenges in the QbD Paradigm
The authors demonstrate how an integrated model is helping to achieve regulatory flexibility. This article is part of a special section on biopharmaceutical trends.
With the dawn of the 2…
Article
Technical and Process Economical Aspects of Using Capto™ Q and ReadyToProcess™Adsorber Q in mAb Polishing
Increasing product titers in upstream cell culture processes pose challenges to downstream purification processes. For efficient operations, downstream purification needs to be able to handle high p…