Search results for " QbD"
Article
Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
While the multiple attributes method gains ground and traditional lab methods improve, broad efforts are underway to determine biopharmaceuticals’ most significant critical quality attributes and en…
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Leveraging Data for Better Biopharmaceutical Process Control
That opens many possibilities for E2E optimization and feedforward control and will make QbD a reality in bioprocessing. We have developed a soft sensor applications for GMP biomanufacturing in which …
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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…
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An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Viral safety needs to be designed into the overall drug-development process and QbD approach.
The concept of product “safety by design” (SbD) represents an integrated, holistic approac…
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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…
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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 …
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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…
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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…
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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…
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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…