Search results for " impurity"
Article
Enhancing Resins Addresses Purification Concerns
Deorkar points out that a major challenge in rAAV purification is the removal of empty capsid particles, which is an impurity generated during upstream processing. “These empty capsids do not contain …
Article
Transformative Medicines Challenge FDA and Manufacturers
…programs to re-evaluate drug substance method validation data and acceptance criteria, to re-examine impurity acceptance criteria based on data from commercial batches, and to conduct stability testi…
Article
SEC in the Modern Downstream Purification Process
Mar 01, 2015
By R. Christopher Manzari, J. Kevin O'Donnell
BioPharm International
Volume 3, Issue 28
Since the introduction of commercial chromatography resins approximately six de…
Article
Challenges of Protein Aggregation During Purification
Careful selection of downstream processing conditions is a must.
Sep 1, 2014
By: Cynthia Challener, PhD
BioPharm International
Volume 27, Issue 9, pp. 32-35
Removal of protein a…
Article
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
For example, an impurity may be determined to severely harm the patient (high severity score) if beyond its limit. If its level does not increase in the process or on stability testing, the occurrence…
Article
QbD and PAT in Upstream and Downstream Processing
To gain perspective on the implementation of quality by design (QbD) and process analytical technology (PAT) in biopharmaceutical processing, BioPharm International spoke with Clinton Weber, as…
Webcast
Trace metals getting you down? Learn what’s really in your cell culture media with Cytiva.
Heavy metal might have a place in your music playlist, but heavy metals should stay out of your cell culture media. Heavy metal impurities in your media can have a drastic effect on cell viability, wi…
Article
Trace metals getting you down? Learn what’s really in your cell culture media
Heavy metal might have a place in your music playlist, but heavy metals should stay out of your cell culture media. Heavy metal impurities in your media can have a drastic effect on cell vi…
Article
Gene Therapies Push Viral Vector Production
Gene Therapies Push Viral Vector Production
Viral vectors show promise as a delivery mechanism for gene therapy, but which virus types are commercially viable?
By Feliza Miraso…
Article
A Look at the Affinity Chromatography Landscape
Beyond impurity removal for “simple” proteins
Affinity chromatography in biologics manufacturing has typically served as a method for removal of process-related impurities such as host-cell protei…