Search results for " GMP"
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On-demand: ÄKTA process™ system virtual demo
Improving usability, efficiency, and reliability were our focus when we designed the new ÄKTA process™ system.
In this virtual workshop Torbjörn Blank will explain how the ÄKTA pr…
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How to Use Multiwell Plates With Manual Operation
During process development, aspects like robustness, scalability, and GMP production come into play. FDA initiatives such as quality by design (QbD) put demands on better process understan…
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A better way to purify small drug volumes
Viral vectors: demand is high and getting higher. But purifying viral vectors with methods optimized for other products can affect yield, purity, and cross-contamination.
How does the …
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Recombinant Adeno-Associated Virus Type 5 Production Process
A scalable recombinant adeno-associated virus (rAAV) type 5 production process was developed using transfected HEK293 suspension cells.
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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…
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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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Traceability in Western Blot Imaging: Considerations for GxP
In regulated environments, electronic record-keeping can improve both traceability and efficiency – but compliance with regulations like Code of Federal Regulations Part 11 and European Union GMP Anne…
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Genetic Vaccine Platforms Demonstrate Their Potential
“The availability of trained, regulatory-compliant GMP manufacturing staff and quality control and quality assurance personnel is a critical success factor,” he says. Much investment in facilities wil…
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Developing a Continuous Large-Scale Perfusion Cell Culture Process
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Perfusion processes enable continuous operation over extended periods of time by constantly providing fresh nutrients for the cells and simultaneously removing spent…
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Innovations in Cell Culture: Manufacturing the Future
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“Innovations in Cell Culture” is a new virtual series from Cytiva, where we will explore and discuss the needs of the biopharma industry with a panel of industry …