Search results for "raw materials"
Article
Supply Chain Challenges for Single-Use Systems
The large number of raw materials makes forecasting demand more difficult and requires robust materials management, supplier quality management, quality control, and business continuity planning to en…
Article
Best Practices in Qualification of Single-Use Systems
• “Processing aids, hazardous or highly toxic raw materials, other special materials, or materials transferred to another unit within the company’s control do not need to be tested if the manufacturer…
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Selecting a Comprehensive Bioburden Reduction Plan
Bioburden may be associated with personnel, incoming raw materials (excipients, APIs, filters, etc.), compendial and non-compendial waters, and ambient air and associated airborne detritus. The potent…
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Technology Innovations Improve Process Chromatography Performance
Although significant work has been done in upstream bioprocessing to remove bottlenecks through the implementation of single-use technologies, better characterization of raw materials, and the use of …
Article
Mapping a Route for Cell and Gene Therapy Process Development
…caught up with the scale required for some of these therapies
- The fact that research-grade raw materials are often used in baseline processes for which equivalent GMP-grade materials or high…
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Improving PAT for Biologics
Implementing PAT for bioprocesses presents unique challenges given the greater complexity of cell-culture and fermentation processes, the variability of raw materials (particularly living organisms), …
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Maximum Output Starts with Optimized Upstream Processing
“Global sourcing of raw materials is an integral part of the supply chain, but recent events have highlighted that relying only on a single source can increase risk during a crisis. Many companies are…
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Best Practices in Adopting Single-Use Systems
To meet these requirements, suppliers should maintain a redundant or backup supply chain for their raw materials. Customers should inquire about a vendor’s contingency plan in the event of a supply in…
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Controlling Cell Culture Process Variability Through Supplier-Enabled Data Management and Analytics
Variability can be reduced across the biopharmaceutical value chain by characterizing raw materials, monitoring materials quality, and controlling raw material usage.
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Single-Use Technologies Prove Effective for Viral Vector Process Development
The benefits of single-use technologies for upstream viral-vector processes clearly outweigh their disadvantages.
Cynthia A. Challener
Upstream viral-vector processes can have sig…