Search results for "aggregates " in Articles / App Notes
Article
Impurity Testing of Biologic Drug Products
“Aggregates are of particular concern, either in soluble dimer/oligomer form or subvisible particle form,” notes Jay Kang, director of analytical and formulation development at Patheon, part of Thermo…
Article
Impact of Media Components on CQAs of Monoclonal Antibodies
Cysteine, along with temperature shift, is believed to reduce protein aggregates and increase their stability in culture harvests. The oxidized form of cysteine has been shown to reduce the formation …
Article
Analyzing Proteins Using SEC, MALS, and UHPLC
Size exclusion chromatography (SEC) is generally used as a non-denaturing method that provides information on the apparent molecular weight, the presence of aggregates or higher molecular weight (MW) …
Article
Evolution of the Monoclonal Antibody Purification Platform
Major Adaptations to the mAb Platform
Use of multiple washes in Protein A
To understand the resolution of fragments and aggregates on Protein A, a pH gradient elution between pH 5.0 and 3.0 over 1…
Article
Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
They then prioritized attributes based on their importance, and found the following to be key:
• Glucose
• Aggregates
• Host cell protein (HCP)
• Cell viability
• Viable cell densi…
Article
Fusion Proteins Pose Manufacturability Challenges
“Frequently, routine cell-culture and purification steps will need to be modified to address the tendency to form aggregates more easily,” notes Kalo.
Some fusion proteins are also prone to proteo…
Article
Virus-like Particles as Therapeutic Moieties of the Future
Analytical and functional characterization of virus-like particles enables process reproducibility and product consistency.
By Ramesh Kumar, Manidipa Banerjee, Anurag S. Rathore
Virus-like…
Article
Moving PAT from Concept to Reality
In addition, a variety of on-line tools measure cell density (dielectric spectroscopy, fluorescence spectroscopy); protein aggregates (size-exclusion chromatography and ultra-high-performance liquid c…
Article
Chromatography for the Diversified Antibody Pipeline
CytivaVideo
In this video, Eva Heldin, Section Manager of Antibody Application in R&D at Cytiva is interviewed by BioPharm International and shares what antibody therapies are in the pipelin…
Article
Reimagining Affordable Biosimilars
Advances in preclinical development play a crucial role in reducing cost for developing biosimilars.
By Anurag S. Rathore, Narendra Chirmule, and Himanshu Malani
Drug development is …