Search results for " drug" in Articles / App Notes
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Process Development and Control for New Modalities
Advancements in technology for manufacturing and online analytical monitoring have not caught up to the innovative drug candidates and emerging modalities present in the candidate pipeline today. Lack…
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Trends in Outsourcing of Bioprocess Development
Many of the biopharma companies behind these drugs are seeking assistance with bioprocess development from outsourcing partners with platform solutions and specialized knowledge, expertise, and techno…
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Analytical Considerations for Successful Upstream Process Development with Spivey and Lane
In 2016, he moved to the drug product science and technology department at BMS.
Today we're talking with him about upstream processes, continuous manufacturing, and just in general how the indus…
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Top Process Development Trends for 2021 and a Look into 2022
…tory oligonucleotides; extracellular vesicles and exosomes such as inherent therapeutic products and drug delivery vector; and plasmids, phages, and microbiome and microbiota. But many challenges are…
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Track-and-Trace Progress Benefits Supply-Chain Security Efforts
“[In the US,] we have been supporting the [pharmaceutical] industry for the final milestone, the Drug Supply Chain Security Act (DSCSA) deadline of November 27, 2023,” says Sturtevant, and advances ha…
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Traceability in Western Blot Imaging: Considerations for GxP
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Densitometry analysis of gels is a key part of quality control in the pharmaceutical drug release process. In regulated environments, electronic record-keeping can improve both tra…
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Preparing for the Future Visions and Insights for Biomanufacturing
Yet, new market dynamics, such as growing competition from biosimilars and niche drugs targeting smaller patient populations, are reshaping how drugs are produced and sold.
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The Future of Biopharma
Günter discuss challenges and opportunities for developing and manufacturing drugs based on cell and gene therapy to treat the symptoms of certain diseases—or even cure diseases completely—as well as …
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Methods Accelerate Biosimilar Analysis
Of the approved drugs, five are biosimilars of trastuzumab; three are biosimilars each of infliximab and adalimumab; two are biosimilars each of filgrastim, pegfilgrastim, etanercept, and bevacizumab,…
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Intensified Chromatography Strategies
The blockbuster drug era is over and drug manufacturers are now striving for a more diversified portfolio by targeting a greater number of monoclonal antibody (mAb) products at lower production volu…