Search results for " design"
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Using Software in Process Validation
and requires a team effort that encompasses people from various disciplines within the plant?
It is important to design processes that ensure product quality, safety, and efficacy. Today’s soft…
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A Look at the Affinity Chromatography Landscape
Significant effort has in fact been directed at designing different libraries of affinity ligands so that structures of choice can be retrieved based on the application, according to Mario DiPaola, se…
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Putting Viral Clearance Capabilities to the Test
The studies must be designed to evaluate potential viruses, be representative of the production process, meet regulatory requirements, and provide reportable data. In addition, the testing should be c…
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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…