Search results for " attribute"
Article
On-Demand Webinar: A Route to Deeper Process Understanding—Studying Resin Variability Using a Process Characterization Kit
Chromatography resin attributes, such as ligand density, can affect critical quality attributes (CQAs) as well as process performance depending on the process design and the separation at hand.
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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 …
Article
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…
Article
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…
Article
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 …
Article
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…
Poster
Strategies for optimized cell culture media: Effectively using design space to influence product quality
Balancing the many individual media components required to achieve high titers and support critical protein quality attributes can be challenging. Here we highlight a statistical design strategy to op…
Article
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…
Article
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…