Search results for " expertise"
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The Importance of Process Intensification and PAT for Achieving Real-Time Release
Analytical labs must have not only the capability (technical expertise and appropriate instruments and software), but the capacity (human, time, and equipment resources) to process these samples and c…
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Strategizing for Rapid Changeovers in Biologics Manufacturing
Overall, Ribault notes that the most important features in a plant management system are people and expertise. “The expertise to run a plant is not in the systems or equipment, but in the team and its…
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Flexible Facilities for Viral Vector Manufacturing
Cytiva has amassed expertise in modular design and construction with the use of its FlexFactory (a modular end-to-end biomanufacturing platform) as well as its KUBio facility (the FlexFactory inside o…
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Reducing Cross-Contamination Risks in Process Chromatography
…ve applications and approaches using existing, widely known used and new products, technologies, and expertise that facilitate continuous processing.
Going 3D
Advanced manufacturing t…
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Contract Manufacturing Through the Years
The private equity firms brought new capital and financial expertise to the industry, along with the concept of the “roll-up” (i.e., making an initial acquisition in the industry and then build out is…
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Being Thorough When Transferring Technology
Detection of residual cytotoxin at the PPB level on the surface of manufacturing equipment requires expertise in the development and execution of ELISA or tandem mass spectrometry (MS/MS)-based analyt…
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GMP Challenges for Advanced Therapy Medicinal Products
They lack the regulatory expertise and resources to establish and operate GMP-compliant manufacturing processes. In particular, they often do not have adequate systems in place for evaluating the qual…
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Modular Manufacturing Platforms for Biologics
Pods, in particular, may be especially useful for emerging markets, points out Emel, “where local construction expertise or materials are not readily available.” In well-developed markets, where the p…
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Biosimilars Development and Supply: How Complex Can the Process Be?
Manufacturers will need to have significant expertise, infrastructure, and investment capital to successfully develop these molecules.
Quality, first-in-class biological therapies have revoluti…
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Quality Considerations for Using AI in Bio/Pharma
“I also worry about if there's the expertise to interpret what the data [are] telling you. You're going to be collecting a lot more data than you've collected before, and data that's new, and how it i…