Search results for " sourcing" in Articles / App Notes
Article
Managing Risk in Raw Material Sourcing
“Best Practices for Effective Excipient Sourcing and Testing,” a Pharmaceutical Technology webcast, September 2016 (archived until September 20, 2017).
2. N. Taleb, The Black Swan: The Impact of H…
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Quality by Design in Biotherapeutics Purification: Understanding and Addressing Sources of Process Variability
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The principles and methodologies of biopharmaceutical manufacturing are well established today. However, the increased molecular diversity br…
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Sources of Bioburden You Might Have Missed
A problem with traditional mAb manufacturing is that there are so many potential entry points for microbial contamination. There are, however, ways to shut the door on contamination.
The risk …
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Your Source of Information for Automated Multistep Protein Purification
Increasing the level of automation in protein purification can free up time and allow other tasks to be performed while the chromatography system is working. Cytiva has gathered recourses to support a…
Article
Securing the Single-Use Supply Chain
Dual sourcing of single-use systems and components was initially proposed as the key solution. After further consideration of the issues surrounding the supply of single-use systems, however, many in …
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Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
But because the chosen methods focused primarily on downstream virus removal or inactivation instead of strategic sourcing of lower-risk starting materials, the efforts had little effect on serum-free…
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Ensuring the Biological Integrity of Raw Materials
“Assuming that all sourcing of raw materials has taken place in a controlled manner, assuming the components are well selected and examined, assuming that all of the testing has been done by the lette…
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Assessing Manufacturing Process Robustness
A structured assessment process can determine compliance to lifecycle process-validation requirements for biopharmaceuticals.
By: Ajay Pazhayattil, Sanjay Sharma, Amol Galande, Marzen…
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The Evolving Role of Starting Materials in Cell and Gene Therapy
Planning for success
Cell sourcing and variability are two of the most important challenges facing the fledgling cell therapy industry. Inconsistent access or inconsistent starting material qualit…
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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…