Search results for " supply chain" in Articles / App Notes
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Testing product and process intermediates alone is helpful, but does not provide a complete solution to viral safety. This article proposes integrated solutions for systemic and proactive viral risk m…
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Security of Supply
This shared understanding leads to supply chain control, and digital makes it possible.
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Drug Quality Key to Innovation and Access
Industry and FDA will face challenges as they continue to implement drug supply chain monitoring programs, as required by the Drug Supply Chain Security Act (DSCSA) of 2013. An immediate task is to pr…
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Regulatory Challenges in the QbD Paradigm
Vendor qualification, supply chain oversight, and sampling and testing plans would be reviewed during the inspection. Variability of raw materials and change management would be assessed. Current emph…
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Report from the 12th Plasma Product Biotechnology Forum
Kedrion’s Director of North America Logistics, Saleh Yusuf further emphasized the supply chain challenges and how increased lead times are impacting patients worldwide. Yusuf informed that on average …
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Single-Use Technologies Prove Effective for Viral Vector Process Development
…red, comprehensive solutions that help users circumvent challenges in terms of sourcing, validation, supply chain, and storage.”
Managing capacity demand
Sourcing has, in fact, become an …
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The New World of Biopharmaceutical Manufacturing
Since the implementation of single-use systems involves a partnership with suppliers, robust and transparent supply chains to the customers are critical.
Linz (Sartorius): The industry…
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Being Thorough When Transferring Technology
Many cell therapies are personalized medicines and these represent unique challenges from a manufacturing and supply chain standpoint. One of the things that can aid greatly in tech transfer for these…
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Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
The producers of these items also need to understand and control their own supply chains and the various components and equipment used in the related processes of their suppliers. Each additional leve…
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Platform Approach Speeds Process Development
A modular cell-culture platform demonstrates accelerated process development.
By Harald Bradl, Jan Bechmann, Benedikt Greulich, Markus Michael Mueller, Patrick Schulz, Thomas Wucherpfennig
C…