Search results for " aggregates"
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
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
Attributes such as residual host-cell proteins, endotoxin, protein aggregates, and biological potency, which may initially be assigned as pCQAs during Phase I development, are highly critical in such …
Article
Elucidating Biosimilars Characterization
With regard to aggregation analysis, size-exclusion chromatography (SEC), often with multi-angle light-scattering detection, is widely used for the determination of aggregates. Other methods employed …
Article
A Closer Look at Affinity Ligands
Affinity ligands play an exciting role in the ever-growing sphere of downstream processing. In speaking with BioPharm International®, Phillip Elliott, PhD, associate director of Process Development,…
Article
Get Started: Purification of mAb Variants - eLearning
These molecules show wider variation in binding affinities and are often more challenging to separate from impurities, such as host cell proteins (HCP), host DNA, aggregates, and isoforms.
In this …
Article
Digitalization: The Route to Biopharma 4.0
However, there are many attributes such as charge variant, aggregates, host-cell proteins, and bioburden that cannot be measured online at present and require sampling and offline analysis (19). Creat…
Article
Optimizing your Cell Culture Process to Improve Productivity
Cell Culture Process
In this video, Mary Szorik and Alicia Elwood at Cytiva, discuss the rationale for cell culture and analytical testing as well as the types of tests that can lead …
Article
Capture of Bispecific Antibodies and Removal of Product-Related Impurities
The biotherapeutics pipeline is becoming increasingly diverse as antibody variants such as bispecifics, conjugates, and fragments move through preclinical stages to commercial manufacturin…
Article
The Importance of Process Intensification and PAT for Achieving Real-Time Release
Creativity and collaboration are required to overcome complex method development challenges.
By Kelvin H. Lee and Mark Lies
…
Article
Technology Innovations Improve Process Chromatography Performance
As technology matures, inefficiencies and process limitations in downstream process chromatography are improved.
By Feliza Mirasol
Selecting an appropriate separation technology fo…