Search results for " design" in Articles / App Notes
Article
Gain Efficiency in Process Development
By carefully designing and evaluating your experiments, sufficient information for optimizing your process can be obtained with a minimal number of experiments. However, process development still dema…
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Roadmap Leads to Innovative Biomanufacturing Strategies
The map then was designed to target these drivers using various metrics. While the most relevant metrics are still evolving, they will be useful in identifying specific deficiencies and eventually est…
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Platform Technologies Improve Protein Expression
…latform technologies for protein expression ranging from the choice of cell line, expression plasmid design, cultivation medium, growth conditions, equipment, scalability, stability, and matching pur…
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Development and Future of Protein A Chromatography Technology: Q&A with Jonathan Royce, Business Leader Chromatography Resins, Cytiva
Several years ago, we started a development project to design and validate the next-generation protein A resin, MabSelect PrismA, which was just introduced to the market. Now, 1M NaOH can in fact be u…
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From Darwin to Recombinant Fc Multimers
In the era of QbD, there has been a lot of focus on Design of Experiment (DoE) approaches. Though considered as a good and established approach, Sejergarrd pointed out several of the inherent drawback…
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Critical Quality Attributes Challenge Biologics Development
Challenges for biologics
BioPharm: Are there specific challenges to identifying CQAs in biologics when applying quality by design (QbD)?
Das (BMS): Knowledge-based design, as opposed to a heur…
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Ensuring the Biological Integrity of Raw Materials
Animals should be less than 30 months old, designated for human consumption, and test free of all forms of transmissible spongiform encephalopathy. And there should be a quality assurance system in pl…
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Fast Turnaround with Automated Column Packing
AxiChrom™ columns have been designed for easy and reliable packing. Preprogrammed, verified, and automated packing methods, together with a purposeful column design, enable one operator to quickly ach…
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Framing Biopharma Success in 2016
FDA’s expedited pathways for drug approval have proved successful; 60% of the 2015 approvals were designated in one or more of the expedited pathways (fast track, breakthrough, priority review, and ac…
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Selecting the Right Viral Clearance Technology
She adds that mapping the design space of a process step for viral clearance is the best way to optimize the step for virus reduction and is the approach generally used to understand the clearance pot…