Search results for " market" in Articles / App Notes
Article
Bioburden Control in the Biopharmaceutical Industry
Microbiological Testing Has its Limitations
Reliance on only quality control tests to judge the safe release of the final product to the market may be misleading because of the nature of the…
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N-Glycan Analysis of Biotherapeutic Proteins
Of these, mAbs represent a large proportion of biotherapeutic glycoproteins and account for approximately half of the biopharmaceutical market, a trend that is set to continue with the advent of biosi…
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Managing Residual Impurities During Downstream Processing
“Laboratory service providers play a critical role in ensuring that their clients, specifically the pharmaceutical industry, only release product to the market place that are safe and efficacious, whi…
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Being Thorough When Transferring Technology
If this is not confirmed, then supplemental process characterization studies, in addition to the process performance qualification (PPQ) runs, can be proposed for the supplemental market authorization…
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Reconciling Sensor Communication Gaps
For Kelsey McNeel, market segment manager, process analytics at Hamilton (Reno, NV), the key issue for bioprocess monitoring and controls is reconciling information obtained at bench- or process-devel…
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Drug Quality Key to Innovation and Access
…n 2015, raising concerns about current incentives and regulatory processes for bringing new drugs to market. FDA has approved numerous breakthrough therapies for cancer and critical conditions based …
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The Tide Stays High
Equity markets’ appetite for public offerings from emerging bio/pharmaceutical companies had significantly diminished: valuations of emerging bio/pharma companies, as measured by the NASDAQ Biotechnol…
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Automating Processes in Upstream Processing
If the place of record for data no longer resides on a paper record, then the integrity of the data, how it is produced and stored in the PCS is a key component for the disposition of batches to the m…
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Modeling Bioreactor Performance
Most widely used are commercially available computational fluid dynamics (CFD) software packages, according to Christel Fenge, vice-president of product management and marketing for fermentation techn…
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Process Chromatography Selection for Downstream Processing Applications
…erra-Arteaga, PhD, purification team manager, MSAT at MilliporeSigma; and Peter Levison, PhD, senior marketing director of Downstream Processes at Pall Life Sciences discuss important considerations …