Search results for "manufacturing"
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The Need for Advanced Process Modeling for New Therapeutic Biologics
The trend toward personalized medicines includes more complex manufacturing cycles that can benefit from advanced process modeling early on in the therapeutics’ development.
By Feli…
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Leveraging Computational Models of Glycosylation for Biopharma QA
Biopharmaceutical glycosylation variability is determined by manufacturing bioprocess conditions (1). Large-scale mammalian cell culture is used for the manufacture of all therapeutic glycoproteins (T…
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Establishment of New Modern Plasma Fractionation Facilities in Asia
… colleagues in the late 1930s and early 1940s, but since that time, substantial improvements in the manufacturing processes have resulted in higher yields, a more diversified product range, and, most…
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CDMOs Driving Emerging Bio/Pharma Success
By Jim Miller
Emerging bio/pharmaceutical companies are going through an unprecedented period of opportunity and growth and have contract development and manufacturing organizations…
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Putting Viral Clearance Capabilities to the Test
When applying for regulatory approval, a drug license holder must demonstrate that its proposed manufacturing process can remove or inactivate potential viral contaminants.
Viral clearance studies…
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Biopharmaceutical Market in Asia: Q&A with Günter Jagschies, Strategic Customer Relations Leader, Cytiva
Korea, Japan, and Singapore, in particular, have a well-established biopharma industry with development and manufacturing capabilities that compete with businesses in North America or Europe at eye le…
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3rd BioProcessing Asia Preview: Q&A with John Curling
…he regulatory environment in Asia
• Prevention rather than cure: vaccine development and manufacturing trends
• Plasma product biotechnology: the changing environment
• Theory and practic…
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Process Development: What May Lie Ahead in 2018?
Single-Use in Full Force
Single-use technology continued to advance from scale-up and clinical applications to clinical manufacturing and the top-10 most popular articles on the Process Developmen…
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What's in Your SOP?
SOPs need to reflect a company’s specific manufacturing or other operations, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
By S…
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Development of Purification for Challenging Fc-Fusion Proteins
A flow-through mode unit operation is generally preferred over bind/elute in manufacturing processes. Advantages can include higher process capacity, smaller column size, shorter cycle time, and, in m…