Search results for " design"
Article
Moving PAT from Concept to Reality
Upstream focus
Most PAT tools that find wide use today are designed for application in upstream processes. “This focus is in large part due to the fact that initial protein quality and effectivene…
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Science Focus Fuels Successful Process Development for Startups
For BriaCell’s CEO, Bill Williams, there are three aspects to process development: process development in the production of its novel therapeutics (both drug substance and drug products), in the desig…
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Challenges in Cell Harvesting Prompt Enhancements
This hermetic design uses mechanical seals to fully isolate product fluid from the outside air, allowing the centrifuge system to be completely filled with liquid and eliminating any air-liquid interf…
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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…
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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…
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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…
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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…
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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 …
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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…
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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…