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.
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
40-47
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…