Search results for " aggregation"
Article
Continuous Manufacturing: A Changing Processing Paradigm
Elimination of process collection and hold steps is a major benefit of continuous processing, concurs Snow, as product degradation and aggregation typically happen in these phases. Langer notes that p…
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Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
An approach for establishing the CQAs of a mAb product by evaluating impact and uncertainty during risk assessment.
A critical quality attribute (CQA) has been defined as “a physical, chemical, …
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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 …
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A Closer Look at Affinity Ligands
The low pH can lead to instability of certain antibodies potentially causing aggregation. A recent innovation is the development of a new generation of Affinity ligands that are like traditional Prote…
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Get Started: Purification of mAb Variants - eLearning
The success of monoclonal antibodies (mAbs) as therapeutics and the multi-domain structure of antibodies has made it possible to create antibody variants, such as bispecific antibodies (bsAbs)…
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Digitalization: The Route to Biopharma 4.0
Industry 4.0, also known as the Fourth Industrial Revolution (4IR), will result in the digital transformation of the manufacturing sector. It is propelled by transformative trends such as the prolif…
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Optimizing your Cell Culture Process to Improve Productivity
We also offer protein quality analysis, including charge variance, glycosylation, and protein aggregation. These types of results provide the scientists information on critical attributes of the prote…
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Capture of Bispecific Antibodies and Removal of Product-Related Impurities
Many of these variants, especially asymmetric bispecific antibodies, are prone to aggregation or to forming product-related impurities such as homodimers and half antibodies during cell culture. The s…
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The Importance of Process Intensification and PAT for Achieving Real-Time Release
Thus, for glycoform, host-cell protein and DNA, protein aggregation/fragmentation, endotoxin, and many other analyses that rely on an array of off-line separation and detection technologies, there are…
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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…