Search results for " aggregates" in Articles / App Notes
Article
Impurity Testing of Biologic Drug Products
“It is well documented that even a small amount of aggregates can cause a significant and sometimes life-threatening immunogenic reaction.”
“Impurities may interact with the therapeutic p…
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
The primary objective of this step is to remove host-cell proteins, DNA, charged variants, and aggregates. Bind and elute mode is used to facilitate removal of product-related impurities.
• A …
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Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
While the multiple attributes method gains ground and traditional lab methods improve, broad efforts are underway to determine biopharmaceuticals’ most significant critical quality attributes and en…
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…
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Virus-like Particles as Therapeutic Moieties of the Future
NTA offers a non-invasive method to quickly analyze size distribution, identify aggregates, and calculate the concentration of particles (20). It is to be noted that enveloped, pleomorphic VLPs typica…
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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
The HIC resins also demonstrated as good aggregate removers—we have the usual suspects such as aggregates, post end proteins, and tricky wholesome proteins. Polishing may be more challenging and will …
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 …