Search results for " polishing"
Article
Addressing the Complex Nature of Downstream Processing with QbD
Quality by design brings both challenges and benefits to the development of downstream processes.
By Susan Haigney
natali_mis/Stock.Adobe.com
Regulators have been en…
Article
Single-Use for Downstream Chromatography: Benefit or Hindrance?
Because chromatography resins make up a large portion of the costs in downstream bioprocessing, switching a polishing step from resin chromatography to a single-use membrane column can significantly r…
Article
Integrated Semi-Continuous Process for mAb Production
In brief, the mAb process consists of perfusion cell culture, continuous capture chromatography, viral inactivation (VI), post VI filtration, batch polishing chromatography, and a final pH adjustment …
Poster
Fast Trak Services: a collaborative project to accelerate downstream biosimilar process development
Process optimization focused on improving the affinity chromatography (AF) capture step as well as the intermediate purification and polishing steps, using hydrophobic interaction chromatography (HIC…
Article
Fusion Proteins Pose Manufacturability Challenges
He does note, however, that for other downstream operations, wider options for polishing chromatography steps to remove aggregates and viral inactivation methods that don’t require low pH treatment ar…
Article
Improving Process-Scale Chromatography
Pall recently introduced a cation-exchange mixed mode sorbent that is effective in post-Protein A mAb polishing when used in conjunction with membrane chromatography in the flow-through mode.
Cyti…
Poster
Guide to modern BioProcess™ chromatography resins
There is an intermediate step where bulk impurities are removed followed by polishing to achieve a final high-level purity. During method and process development, chromatography resins are selected an…
Article
Process Chromatography Selection for Downstream Processing Applications
The use of activated carbon as an adsorbent in polishing steps is gaining attention in the industry. This technology can provide good host cell protein removal within a relatively broad operating wind…
Poster
Modes of controlling charge variant distribution in Mab production
Furthermore, the MAb charge variant clearance in the downstream chromatography polishing step was evaluated.
Article
Cleaning of Dedicated Equipment: Why Validation is Needed
This article discusses cleaning validation of equipment dedicated to the production of a single API.
By Cristina Baccarelli, Paola Bernard, Teresa Cortellino, Oscar Cruciani, Rita Pacello, Chi…