Search results for "manufacturing" in Articles / App Notes
Article
Evolution of the Monoclonal Antibody Purification Platform
This 31st article in the “Elements of Biopharmaceutical Production” series focuses on evolution of the purification platform for manufacturing of mAb therapeutics.
Traditional Mon…
Article
Navigating Emerging Markets: Middle East and North Africa
The pharmaceutical industry grows despite conflict in the Middle East.
The Middle East and North Africa have been rocked in recent years by upheaval ranging from moderate protest to full…
Article
Report from the Eighth International Plasma Product Biotechnology Meeting Melia Salinas, Lanzarote, Spain
The meeting was divided into different scientific sessions focusing on issues and possibilities around manufacturing, development and clinical use of plasma products in general. In addition, a poster …
Article
Essentials in Quality Risk Management
…uality attributes (CQAs) are defined and maintained from phase to phase during drug development and manufacturing and changes in drug-product formulation, definition, analytical method, and associate…
Article
The Future of Biopharma
These competitors are expected to compete on the basis of price; therefore, low manufacturing costs will be required. This low-cost requirement is driving many companies to seek out and adopt bioproce…
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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…
Article
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…
Article
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…
Article
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…