Search results for "quality" in Articles / App Notes
Article
Setting Up Bioprocessing Systems for Digital Transformation
“Today, quality teams must also verify that nobody changed the configuration of the system, which might impact the measurement. It is no longer enough to demonstrate that the temperature value was cor…
Article
Technology Innovations Improve Process Chromatography Performance
Data can help quality and process optimization engineers gain deeper insight into complex material interactions in downstream process steps, particularly related to raw material characterization, Deor…
Article
Mechanistic Modeling: Current Advantages and Future Opportunities in Biopharmaceutical Process Development
Also, ChromX offers multiple helpful features, including the ability to facilitate data import from ÄKTA™ systems and finding correlations between process parameters and quality attributes. But t…
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
The Need for Advanced Process Modeling for New Therapeutic Biologics
FDA’s quality-by-design (QbD) and validation initiatives also encourage the use of modeling early on.
While QbD does not define manufacturing design space or specific protocols, it does discuss…
Article
New Therapies Present Scaling Challenges
…n be used to support the increased manufacture of allogenic cell therapies, provided that a product quality profile for the allogenic cell therapy has been established and is well understood (2, 3). …
Article
Design Considerations for a Commercial Cell and Gene Therapy Facility
Common to each, however, would be design criteria to minimize risk in manufacturing, including unidirectional flow of personnel and materials in the cleanrooms, proximity to a quality control lab for …
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
Achieving Process Balance with Perfusion Bioreactors
single use
Long process durations, high oxygen transfer rates, and short mixing times are not a challenge for quality stainless-steel bioreactors equipped with double mechanical seals or magnetic …
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 …