Search results for "manufacturing" in Articles / App Notes
Article
Biopharma Advances Demand Specialized Expertise
The approval of the first biosimilar in the United States, as well as continuing consolidation in the biopharma and contract development and manufacturing markets, are just two indicators of the ongoi…
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Single-Use Technologies Prove Effective for Viral Vector Process Development
These advantages, according to Atul Mohindra, senior director of R&D for Lonza, drive down overall contamination rates as well as enhance the efficiency of a production facility while reducing manufac…
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Biopharma Seeks Balance
The strategic shift by small companies to focus on rare or orphan diseases that afflict smaller populations altered research and manufacturing processes and also changed business models. Big Pharma sp…
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Taking a “Development-by-Design” Approach to Cell Therapies
This has been traced to problems with manufacturing and failure to understand process requirements earlier in the development process. Table I outlines manufacturing issues.
As a growing number of…
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Biosimilars Development and Supply: How Complex Can the Process Be?
Developing a high-quality biologic medicine that is safe and effective also requires a commitment to manufacturing excellence. Innovator companies often need to invest up to $1.2 billion to bring a bi…
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Remote Monitoring and Big Data Advance Upstream Automation
Challener
As upstream processing drives toward higher efficiencies in meeting demand, it requires optimizing the current state of manufacturing with the goal of achieving real-time release and an …
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State of the Biopharmaceutical Industry: Lessons from 2018 Survey Data
of Rockville, MD, has surveyed developers of biotherapeutics and contract manufacturing organizations working in this space about current and projected capacity and production. The results, published …
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FDA Framework Spurs Advanced Therapies
ISCT also expects the recent approvals to spark considerable investment across all stages of drug development from fundamental research within academia to commercial manufacturing by Big Pharma and co…
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Best Practices in Qualification of Single-Use Systems
The dynamic nature of SUS provides excitement for professionals from both suppliers and end users, who predominantly believe that SUS is a key technology for the future of biomanufacturing because of …
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FDA Seeks Metrics to Define Drug Quality
Seeking metrics
In crafting the shortages plan, an FDA Drug Shortages Task Force has been examining more broadly how drug manufacturing problems may precipitate plant closings and product discontin…