Search results for "manufacturing"
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Need solutions for large-scale production of mRNA-based molecules?
mRNA therapeutics offer precise and individualized therapy and avoid manufacturing issues associated with recombinant proteins. Compared with current therapeutics, mRNA production is more cost-effecti…
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Enhancing Resins Addresses Purification Concerns
Therefore, removal of these empty capsid particles is critical during the manufacturing process,” he states.
Use of AEX resins, which rely on the difference in charge between the empty and f…
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Cytiva Advances Fiber Chromatography Technology with New Launch
Fibro PrismA uses the same chromatography systems, infrastructure, and ligands as resin chromatography, which allows for simple transition into existing biomanufacturing facilities.
The Fibro tech…
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How To Execute Successful Data Migrations
For example, audit trails that capture data maintenance of raw materials, components, and ingredients must not only migrate in a good manufacturing practice (GMP)-compliant manner but should also be F…
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Cytiva Introduces the Xcellerex Automated Perfusion System
“Along with our end-to-end flexible manufacturing solutions, automation technology, and trusted expertise, we have introduced Xcellerex APS to support the industry’s journey to integrated continuous m…
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2019’s Top Bioprocessing Trends and What to Expect in 2020
FDA approvals announced during the year for cell and gene therapies prompted the need to consider manufacturing facility designs specific to cell and gene therapy workflows, as well as the need to exp…
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A Diverse Landscape of Patent Issues Seen in the US, UK, and the EU
A Diverse Landscape of Patent Issues Seen in the US, UK, and the EU
Legal experts in biopharmaceutical patent law shed some light on trends and recent news.
By Agnes Shanley
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Addressing the Complex Nature of Downstream Processing with QbD
Specifications for the drug substance, excipients, and drug product and controls for each manufacturing step are determined through a control strategy. The final elements of QbD are process capability…
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Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
A major advantage of SPR-based analysis is its ability to estimate the association and dissociation rate constants, an …
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Advances in Engineering of Protein-Based APIs
…bility, which provide improved delivery for desired patient outcomes and improved processing during manufacturing. Incorporating patient needs into molecule designs starts with a translation of the t…