Search results for " raw material"
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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…
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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
The identified risks and severity levels inform planning of raw material selection, facility design, process elements and conditions, cleaning and sanitization requirements, establishment of alert/act…
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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 …
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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 hig…
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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
When raw material variability issues arise, manufacturers and suppliers must address them immediately by analyzing data, determining the root cause, and minimizing the variability. Variability can be …
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Single-Use Technologies Prove Effective for Viral Vector Process Development
…erived components pose an additional risk for the introduction of adventitious agents and biological raw material consistency, which can result in more biological variation than chemically defined me…