Search results for " QbD" in Articles / App Notes
Article
Taking a “Development-by-Design” Approach to Cell Therapies
Mazzo, arguably one of few life-science company CEOs to even articulate the QbD concept, explains that the company has gone a step further, and broadened the International Conference on Harmonization …
Article
Use of Multivariate Data Analysis in Bioprocessing
Conclusion
With continued efforts towards implementation of QbD and PAT in the biotech industry, MVDA is expected to continue to serve as an enabler of this change. The authors see great scope for…
Article
Technologies and Practices Must Evolve to Meet Demand
More than 76% of the 2015 respondents reported improved process understanding; nearly 60% cited increased efficiency or reduced waste as a result of implementing QbD. Barriers to implementation remain…
Article
Improving PAT for Biologics
The complexity of biopharma processes requires innovative solutions.
Dec 01, 2014
By Cynthia Challener, PhD
BioPharm International
A key component of the quality-by-design (QbD) ap…
Article
Global Expansion Shapes Drug Oversight
… new drug applications and supplements, an initiative designed to provide consistency and clarity to QbD policies.
At a London meeting in April, senior leadership from FDA, EMA, and the Europe…
Article
Q&As with Industry Leaders
… Lester, Co-Organizer of the HTPD Conference
The Future of QbD, Part 1
Dr. Anurag Rathore, Professor, Department of Chemical Engi…
Article
Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
ISPE, Product Quality Lifecycle Initiative (PQLI) Good Practice Guide, Part 1 - Product Realization using QbD, Concepts and Principles (Tampa, FL, Nov 2010).
10. ISPE, Product Quality Lifecycle In…
Article
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
ISPE, Product Quality Lifecycle Initiative (PQLI) Good Practice Guide, Part 1-Product Realization using QbD, Concepts and Principles (2011).
10. Parenteral Drug Association, Technical Report 60, P…
Article
A risk based approach to sterile filtration
Drug quality cannot be assured only by finished-product testing. Process validation is required to establish scientific evidence that a process is capable of delivering an effective and safe …
Article
Quality by design in biotherapeutics purification white paper
Learn how understanding and addressing variability sources can help you develop robust chromatography processes. The principles and methodologies of biopharmaceutical manufacturing are well …