Search results for "Biomanufacturing"
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Digital Technologies Aid Productivity and Growth
Digital technologies can improve productivity and growth in cell therapy manufacturing and in bioprocessing. By applying remote monitoring solutions, advanced modeling, and optimization of manufactu…
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Fifteen Years of Progress: Biopharmaceutical Industry Survey Results
WuXi Biologics, “WuXi Biologics to Invest €325 Million to Build Largest Biomanufacturing Facility Using Single-Use Bioreactors in Ireland,” Press Release [4], April 30, 2018.
5. R.A. Rader, E.S.…
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Modern Manufacturing Key to More Effective Vaccines
Modern Manufacturing Key to More Effective Vaccines
Accelerated development of new preventives raises challenges for efficient CMC evaluation and production.
By Jill Wechsler
…
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Taking Prepacked Columns to Manufacturing Scale
Prepacked chromatography columns in biomanufacturing can save time, but also present concerns related to delivery lead times, capacity, and operational cost.
Learn more here about ways to address…
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Preclinical Evaluation of Product Related Impurities and Variants
Preclinical Evaluation of Product Related Impurities and Variants
The approaches for sample preparation of preclinical evaluation of safety and efficacy are addressed taking into consideration the s…
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QbD Improves Cell-Culture Process Control
QbD Improves Cell-Culture Process Control
A quality-by-design approach that implements PAT offers advantages in upstream cell-culture processing.
By Feliza Mirasol
Mar…
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Reducing Cross-Contamination Risks in Process Chromatography
“Reducing parts in a manufacturing process benefits industries like the biomanufacturing industry, where the processes and manufacturing equipment can be complex and made up of hundreds of different p…
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Modeling and Miniaturization: Key Topics at Successful HTPD Conference
Bill Whitford from Cytiva presented an extensive overview on “Process Development in the Digital Biomanufacturing Age” with digital twins and data-mining strategies. Carsten Radtke from Karlsruhe Inst…
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Manufacturing Standards Key to Advancing Cellular and Gene Therapies
NIST, Regenerative Medicine Biomanufacturing, NIST.gov.
5. FDA, FDA Briefing Document, Oncologic Drugs Advisory Committee Meeting, BLA 125646.
6. Novartis, “Oncologic Drugs Advisory Comm…
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Automated In-Line Buffer Preparation from Ready-Made Stock Solutions in a mAb Process Step
Buffer preparation is both time-and space-consuming and can easily become a challenge in biomanufacturing. This application note describes a lean approach to buffer preparation by implementing in-li…