Search results for " QbD" in Articles / App Notes
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
Prior to QbD, pharmaceutical development did not require the establishment of functional relationships between CPPs and CQAs. Consequently, process characterization experiments were primarily univaria…
Article
State of Quality and Compliance in the Biopharmaceutical Industry
QUALITY IMPROVEMENT INITIATIVES
PAT, QbD, Quality, and cGMPs for the 21st Century are meant to provide increased understanding, control, and reliability of manufacturing processes, as well as c…
Article
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
If used correctly, these new analytical methods can reduce analysis and product development time.
ABSTRACT
Monoclonal antibodies represent a significant portion of sales in the biopharma…
Article
Essentials in Quality Risk Management
Quality risk management is an essential element of every aspect of drug development and manufacturing throughout the product lifecycle.
Quality risk management (QRM), as defined in Internatio…
Article
Eliminating Residual Impurities Starts with a Strategic Plan
Savoy also recommends that methods be developed following an analytical QbD approach.
Specific factors to assess for possible impurities include requirements established in regulatory guidelines…
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…
Article
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 …
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
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…
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…