Search results for "metric"
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HyClone Characterized FBS – Origin Equivalence Study
With that in mind, we evaluated HyClone-brand characterized FBS from the United States, New Zealand, and Australia on several performance metrics.
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Reimagining Affordable Biosimilars
While considerably lower than the corresponding metrics for development of novel biotherapeutics, they are at least a log higher than those required for small-molecule generic molecules. Other challen…
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Oligonucleotide Therapeutics Heading for Tons of Quantity in Annual Supply Need
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Solid-phase flow through technology poised to annually produce metric tons (1000 kg) provides the oligonucleotide therapeutic industry efficient synthesis t…
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Moving PAT from Concept to Reality
…ologies that will cover all of downstream processing for all molecules and their associated quality metrics.
Next-generation therapies are creating additional opportunities for PAT adoption, thou…
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Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
Initially, Thermo Fisher Scientific incorporated MAM capabilities into several product lines, but since that time, Agilent, Protein Metrics, Genedata, Sciex, Bruker, and Waters, have also developed pl…
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Using Multiple Techniques in Biosimilar Analysis
While the small size of the peptide likely precludes structural relevance to the fitting values, they can serve as a comparative metric between samples. The spectra suggest that, while the samples sho…
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Single-use Bioreactors Have Reached the Big Time
“When considering the workflow and objectives of running bioreactors, recent developments have focused on reducing complexity, improving mixing to achieve higher volumetric mass transfer coefficients …
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Going Small to Achieve Success on the Commercial Scale
While the inability to demonstrate equivalence between scaled-down and large-scale operations is often inevitable for some metrics, further understanding of these scale-related differences, particular…
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USP Stresses Pharmacopeial Standards at CPhI China
The USP requirements for elemental impurities, FDA’s metrics program, and the generic-drug market were also discussed.
USP stressed the need for compliance with global regulations and standards du…
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Biopharma Outsourcing Activities Update
And on this metric, certain aspects of outsourcing don’t seem to have slowed at all.
When the percentage of the various activities being outsourced today is estimated, approximately half are being …