Search results for " design" in Articles / App Notes
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mAbs to Watch in 2016
Obiltoxaximab was granted Fast-Track status and Orphan Drug Designation by FDA, according to the company.
Atezolizumab—This fully humanized mAb immunotherapy is the product of a collaboration betw…
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Securing the Single-Use Supply Chain
Philips notes that with limited standards in place, variation in SUS design continues to be significant, and it is much harder to have contingency in supply. Hudson agrees that the main challenge to d…
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Challenges in Analytical Method Development and Validation
Quality by Design
BioPharm: How can method validation benefit from a QbD approach?
Krause (MedImmune): For a QbD approach for analytical methods, the analytical method lifecycle stages should co…
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The Lifecycle Change of Process Validation and Analytical Testing
…APPLYING PAT
BioPharm: How may a given manufacturing process (including equipment design and operation) and analytical testing need to be modified to accommodate this lifecycle approach?
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Next Generation Process Chromatography
One of the main remaining challenges is that each purification cycle today typically takes >3 hours, and when considering ancillary operations, a typical bioprocess designed today will usually run thi…
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Mapping a Route for Cell and Gene Therapy Process Development
There is also a need for appropriately designed equipment and technologies. These factors make process development and validation for cell and gene therapies a challenging and highly critical task.
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Monitoring and Control of Inline Dilution Processes
Successful implementation of automated solution like IC and ILD then requires selection of the design option best suited for the specific process needs, considering the number of buffers to be u…
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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…