Search results for " design" in Articles / App Notes

Article Leveraging Data for Better Biopharmaceutical Process Control
Monitoring calibration models could be built and used across lifecycle and process scales only if very detailed care was taken in designed experiments during calibration development (2) to avoid ‘indi…

Article Understanding Validation and Technical Transfer, Part I
It is not a stack of protocols and reports designed to satisfy regulatory expectations. It is not following by rote a series of “qualifications” such as design (DQ), installation (IQ), operational (OQ…

Article Transformative Medicines Challenge FDA and Manufacturers
He emphasized the importance of establishing and evaluating device design controls early in drug development and of ensuring compatibility of the components, as drug viscosity may affect syringe desig…

Article ADC Development Robust Despite Lackluster Performance
The agency also awarded the ADC a fast-track designation. If approved, the ADC will join Eisai’s eribulin, for treating metastic liosarcoma, and Novartis’ ofatumumab, for treating recurrent or progres…

Article The New World of Biopharmaceutical Manufacturing
That might imply driving toward standardization from different perspectives: designs, interconnectivity, technical qualification packages, certificates, manufacturing practices, and product lifecycle …

Article Advancing Single-Use Technology Through Collaboration
…offers a single user voice that answers common questions suppliers might have about the scope, study design, sample preparation, analytical methods, and reporting involved in extractables testing. “T…

Article Platform Approach Speeds Process Development
Chinese hamster ovary (CHO)-based cell culture platforms should combine state-of the-art technologies for genetic vectors, host cell portfolio, cell line generation, cultivation media, and process des…

Article Going Small to Achieve Success on the Commercial Scale
What counts as a scale-down model? A scale-down model is a bench-scale process designed to predict the results that will be obtained when the process is run at commercial scale. Unlike initial pro…

Article Fluid Handling in Biopharma Facilities
Disposables could represent a significant benefit in terms of facility design, validation, and investment. This trend will continue to grow as single-use systems increase a product’s speed-to-market a…

Article Cleaning of Dedicated Equipment: Why Validation is Needed
As for non-dedicated facilities, equipment should be of appropriate design and adequate size and suitably located for its intended use, cleaning, and sanitation (2). Design and technical aspects of eq…

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