Search results for "qbd" in Articles / App Notes
Article
Taking a “Development-by-Design” Approach to Cell Therapies
NeoStem and PCT, like a growing number of companies, are taking the principle of quality by design (QbD) to heart in their work.
Mazzo, arguably one of few life-science company CEOs to even articu…
Article
Use of Multivariate Data Analysis in Bioprocessing
The increasing use of MVDA has also been fueled by the increasing acceptance of quality by design (QbD) and process analytical technology (PAT) among regulators and the biotech industry. Implementatio…
Article
Technologies and Practices Must Evolve to Meet Demand
Process improvement efforts
In the 2014 survey, 68% of the respondents indicated that their companies had implemented quality by design (QbD). In the 2015 survey, this number grew to 72.5%. More t…
Article
Improving PAT for Biologics
Dec 01, 2014
By Cynthia Challener, PhD
BioPharm International
A key component of the quality-by-design (QbD) approach to pharmaceutical manufacturing is the implementation of process ana…
Article
Global Expansion Shapes Drug Oversight
…g renewal of a pilot program that allows for parallel review and consultation on quality-by-design (QbD) components to new drug applications and supplements, an initiative designed to provide consist…
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 Engin…
Article
Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
This approach is not consistent with the current quality-by-design (QbD) approach to process validation and will not be sufficient to defend a final NOR establishment. Issues with Option 2 have been d…
Article
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
As the pharmaceutical industry tries to embrace the methodologies of quality by design (QbD) provided by the FDA’s process validation (PV) guidance (1) and International Conference on Harmonization (I…
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 …