Search results for "qbd" in Articles / App Notes
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
…ion (ICH) Q8(R2), Q9, and Q10 guidelines provide the foundation for implementing Quality by Design (QbD). Applying those concepts to the manufacture of biotech products, however, involves some nuance…
Article
Challenges in Analytical Method Development and Validation
Technologies, such as FDA’s quality-by-design (QbD) initiative, may have a positive impact on analytical method development and validation according to Paul Smith, EMEAI laboratory compliance producti…
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
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The biotech industry has begun to implement a quality-by-design (QbD) approach to ensure the quality of biopharmaceuticals. Using this approach, products are developed with a thorough under…
Article
Quality by Design and Extractable and Leachable Testing
…r and resembles a “quality-by-QC test” strategy, rather than a more sensible quality-by-design (QbD) strategy that is expected today. If harmful leachables are found during stability studies, one wou…
Article
Using Quality by Design to Develop Robust Chromatographic Methods
The concept of quality by design (QbD) was introduced to the pharmaceutical industry in the International Conference on Harmonization (ICH) guidance documents, ICH Q8-Q11 (1-4), as a way to develop ro…
Article
Continued Process Verification for Biopharma Manufacturing
CPV and Quality by Design
Quality by design (QbD) means scientifically building quality into a product and the process by which it is developed and manufactured. QbD is based on the systematic ide…
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…