Search results for " attribute" in Articles / App Notes
Article
Biomanufacturing Outsourcing Globalization Continues
For example, in the 2014 study, a CMO being “local to me” was the least important of 19 CMO attributes that were measured.
Top outsourcing destinations
Offshoring for biologics has been genera…
Article
Use of Multivariate Data Analysis in Bioprocessing
…ding of any underlying relation or interaction between process variables and the product and process attributes. To this end, the literature is replete with works of many researchers engaged in vario…
Article
Re-use of Protein A Resin: Fouling and Economics
These attributes can result in differences in binding capacity, resin compressibility, chemical resistance, permeability, available surface area, and mass-transfer properties, all of which significant…
Article
Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability
It is, therefore, important to have a systematic and quantitative assessment of quality attributes to pick out those that are crucial based on their clinical relevance. These critical attributes are o…
Article
Implementing QbD in Sterile Manufacturing
Critical quality attributes
BioPharm: In implementing a QbD approach, what would you identify as the critical quality attributes (CQAs) in sterile manufacturing and aseptic processing?
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Article
Essentials in Establishing and Using Design Space
Design space is generally considered to be the areas where the product or process parameters can be run safely (without failure or high amounts of degradation) and achieve all critical quality attribu…
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Essentials in Quality Risk Management
Quality risk management (QRM), as defined in International Conference on Harmonization's (ICH) Q9 document (1), is designed to ensure that drug critical quality attributes (CQAs) are defined and maint…
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Analytical Considerations for Successful Upstream Process Development with Spivey and Lane
Balancing critical process parameters against competing requirements for critical quality attribute (CQA) specifications. We also touch upon continuous versus batch manufacturing.
Topics…
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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