Search results for " attribute" in Articles / App Notes
Article
Mapping a Route for Cell and Gene Therapy Process Development
Reducing manufacturing costs, as well as development of scalable, automated manufacturing processes under closed systems that can reach the target quantities while maintaining the critical quality att…
Article
Methods Accelerate Biosimilar Analysis
Using this new generation of equipment introduced in the past five years, it is possible to extract several product attributes by simply determining the intact mass of the molecule. The data provided …
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An Analytical Approach to Biosimilar Drug Development
That is due to the natural variability and inherent complexity in manufacturing of biologics for which the demonstration of identical quality attributes (pharmaceutical equivalence) as required by the…
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Advances in Engineering of Protein-Based APIs
Antibody-drug conjugates are a second-generation version leveraging the attributes of both small and large molecules. Bi/multispecific and fusion proteins are emerging as promising third-generation pr…
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Using Multiple Techniques in Biosimilar Analysis
Standard testing routines comprise a selection of experimental techniques chosen because of their ability to monitor various quality attributes of the molecule. These are typically among those listed …
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QbD Improves Cell-Culture Process Control
In addition, this use of PAT would allow for on-line prediction of the critical quality attributes (CQAs) required to maintain product quality and offer the ability for real-time product quality contr…
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Platform Approach Speeds Process Development
Depending on the project objectives, product gene optimization is performed to improve expression rates and modulate particular product quality attributes or product properties.
Currently, the maj…
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What’s In a Name? For Biosimilars, A Lot
…ph—understanding that the monograph tests and acceptance criteria describe a subset of the quality attributes of the articles in question and do not make a statement about their regulatory status, cl…
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Ensuring the Quality of Biologicals
has established general monographs that cover common quality attributes and that are applicable to a specific class of biologicals such as monoclonal antibodies (mAbs), rDNA products, or vaccines for …
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USP Publishes Monoclonal Antibody Guidelines
Unlike small-molecule medicines, which have more easily defined quality attributes and are relatively easy to characterize, biologics are large-molecule drugs, typically manufactured using living cell…