Search results for " purification"
Article
Viral Clearance Challenges in Bioprocessing
42-44
Removal and inactivation of adventitious and endogenous viruses have traditionally been achieved during the downstream purification of biologics. Viral clearance is assessed in small-scale te…
Article
Evaluating the Use of Continuous Chromatography
In downstream processing, continuous chromatography is gaining traction in the purification of protein therapeutics. As the biopharmaceutical industry strives to demonstrate, continuous manufacturing …
Article
Preclinical Evaluation of Product Related Impurities and Variants
The level of these species, however, is usually controllable through fermentation and purification steps. There is no consensus among the regulatory agencies on the maximum allowable limit for these s…
Article
Process Chromatography Selection for Downstream Processing Applications
Important factors such as column design, resin development, and automation have all played a role in simplifying the purification process, in some cases reducing it from five steps to three (1). Selec…
Article
Optimizing Resin Performance with Disposable Chromatography Solutions
The chromatography medium is the means by which protein purification is performed, and it must perform as expected, otherwise the purity of the drug can be impaired. Customers have expressed that they…
Article
Bioprocessing Advances in Vaccine Manufacture
…portable bioprocessing facilities
•Novel expression systems/improved cell lines
•New purification technologies.
As these technologies advance and are increasingly adopted for…
Article
Exosome isolation by tangential flow filtration and size exclusion chromatography
We describe an evaluation of purification workflows from three different cell culture supernatants. The workflows we describe are suitable for scale-up and combine tangential flow filtration (TFF) for…
Article
Updating Viral Clearance for New Biologic Modalities
For traditional downstream processing templates, such as monoclonal antibody (mAb) purification, the technologies used to ensure virus removal are well established and their effectiveness has been con…
Article
Eliminating Residual Impurities Starts with a Strategic Plan
…ce that may include a limit specification in a release test or validating the removal during product purification. Others are more complex to define, such as those that originate from the cellular sy…
Article
Cytiva Opens Biotechnology Manufacturing Center in UK
In the first half of 2019, the center will start producing a fiber-based chromatography purification platform, which has the potential to improve efficiency in the purification steps of manufacturing …