Search results for "qbd" in Articles / App Notes
Article
Critical Quality Attributes Challenge Biologics Development
Challenges for biologics
BioPharm: Are there specific challenges to identifying CQAs in biologics when applying quality by design (QbD)?
Das (BMS): Knowledge-based design, as opposed to a heur…
Article
What Drove Biopharma Development in 2014?
One of them is Quality-by Design (QbD). As federal agencies continue to push for proof of quality in biologics, there is increased interest in, and use of, QbD in pharmaceutical development and that t…
Article
Assessing Manufacturing Process Robustness
…es and equipment
validation of analytical methods per analytical quality by design (QbD) as per ICH Q 14
utilization of cumulative data from all relevant studies to es…
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Quality Systems Key to Lifecycle Drug Management
FDA officials have long proposed that manufacturers implementing quality-by-design (QbD) approaches and quality controls should be able to manage postapproval changes with less regulatory oversight. T…
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Biosimilars Development and Supply: How Complex Can the Process Be?
As the complex requirements of manufacturing biologics are manifold, it is important that biomanufacturing companies adopt quality-by-design principles.
Countries around the world face a gro…
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A Look Ahead at BioPharma Manufacturing and Regulation
…excipients and complex dosage forms, and process analytical technology (PAT) and quality-by-design (QbD) approaches. What does FDA and the industry hope to gain by focusing on these areas?
…
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How to program, run and evaluate a design of experiments (DoE)
In this free, interactive course, Dr. Martin Sichting, Product Manager Lab Scale Chromatography Systems at Cytiva, guides you through the DoE process.
You’ll learn how to program, run, and e…
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Efforts Accelerate to Streamline Postapproval Change Process
Manufacturers and regulatory authorities seek coordinated lifecycle management policies.
By Jill Wechsler
Frequent revisions and updates in manufacturing processes and operations are routine…
Article
Mechanistic Modeling: Does it Have a Future in Process Development?
Statistical models based on QbD sometimes fail. When you set up a statistical model based on DoE, you don’t really know if you have all the right parameters in play and whether or not you’ve taken eve…
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Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
Identifying CQAs for a biotech therapeutic is the first and arguably the most difficult step in implementation of quality by design (QbD) for development and production of biopharmaceuticals (3, 4). …