Search results for "qbd"
Article
Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
Complexity—in particular, determining which product attributes are most crucial to product quality and patient safety—makes it challenging to apply quality-by-design (QbD) methods and process analytic…
Article
Leveraging Data for Better Biopharmaceutical Process Control
Today, they are being used across operations, making true the promises of quality by design (QbD). In time, they may even permit the use of real-time release (RTR) in bioprocessing. As data managemen…
Article
From Darwin to Recombinant Fc Multimers
Damien Bataille from LFB presented how affinity chromatography with a novel chromatography resin, VIISelect, together with a QbD approach, delivered a robust process control strategy to deliver a high…
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Product safety and quality by design (QbD)
Traditionally, product safety has relied on the incorporation of three key measures into the manufacturing process: selection, testing, and viral clearan…
Article
Going Small to Achieve Success on the Commercial Scale
The impact of QbD and DoE
The quality-by-design (QbD) approach to process development requires characterization of the impacts of different process parameters on product critical quality attribute…
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…