Search results for " QbD" in Articles / App Notes

Article Critical Quality Attributes Challenge Biologics Development
…D)? Das (BMS): Knowledge-based design, as opposed to a heuristic approach, is a key principle of QbD. Determination of criticality of process and quality attributes improved significantly in the …

Article What Drove Biopharma Development in 2014?
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 trend is only expected to rise. According…

Article Assessing Manufacturing Process Robustness
Data gaps identified at Stage 1 QbD, Stage 2 equipment/facility/utility qualification and PPQ, and Stage 3 continued process verification require that a sampling and testing plan be developed under a …

Article Quality Systems Key to Lifecycle Drug Management
FDA officials plan to try again to offer regulatory relief in filing supplements and also in undergoing plant inspections for those biopharma companies that implement QbD and advanced manufacturing te…

Article 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…

Article A Look Ahead at BioPharma Manufacturing and Regulation
By applying QbD and understanding the role of excipients and complex dosage forms, a higher level of product and process understanding will be obtained. The other approaches (PAT, continuous manufactu…

Article 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…

Article 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…

Article Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
This comparison in the QbD paradigm also centers around the CQAs.  The European Medicines Agency’s guideline covering “Production and Quality Control of Monoclonal Antibodies” requests that “the m…

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