Search results for " attribute"
Article
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
If used correctly, these new analytical methods can reduce analysis and product development time.
ABSTRACT
Monoclonal antibodies represent a significant portion of sales in the biopharma…
Article
Flexibility in Biopharmaceutical Manufacturing
Flexibility is another must-have attribute, and although everyone wants it, you're likely to get a wide spectrum of definitions when you ask what it is.
With such a diverse view on what flexibi…
Article
Advancing QbD in the EU
…uality assurance or an "enhanced" structured approach, which involves concepts like critical quality attributes (CQA), design space, and control strategies.
The industry has been urging EU aut…
Article
PDA's Technical Report for Biotech Cleaning Validation
A key to cleaning-process design is an understanding of the cleaning process itself, including critical quality attributes (CQAs) related to the outcome of the cleaning process, as well as critical pr…
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