Search results for " QbD"

Webcast e-Learning: what is quality by design (QbD)?
The focus lies on applying QbD to process development of biopharmaceuticals. 

Webcast e-Learning: what is quality by design (QbD)
The focus lies on applying QbD to process development of biopharmaceuticals.  

QBD

Regulatory/QbD

Article Quality by Design—Bridging the Gap between Concept and Implementation
A relatively small number of marketing approval applications made in Europe have supporting QbD data, with EMA conceding that application dossiers with QbD information are far from becoming a standard…

Article Quality by design for biotechnology products—part 1
Therefore, this paper offers guidance and interpretation for implementing QbD for biopharmaceuticals, from early-phase development steps such as identifying critical quality attributes and setting spe…

Article Challenges in Analytical Method Development and Validation
Quality by Design BioPharm: How can method validation benefit from a QbD approach? Krause (MedImmune): For a QbD approach for analytical methods, the analytical method lifecycle stages should co…

Article Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
Although the phrase QbD has been thought of as a new or borrowed concept and discussed in terms of feasability, many CMOs have been using these concepts, albeit perhaps not in a well-planned, cohesive…

Article Addressing the Challenges in Downstream Processing Today and Tomorrow
Furthermore, with the increasing emphasis on Quality by Design (QbD), there is a need to develop paradigms to apply QbD not only to mAbs but also to other BioTx. Early biotechnology products in th…

Article Application of Quality by Design to Viral Safety
A QbD approach to drug development starts with the definition of critical quality attributes (CQA) that the final drug product will possess, and then outlines the development path to achieve these goa…

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