Search results for " GMP" in Articles / App Notes
Article
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 …
Article
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 …
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How To Execute Successful Data Migrations
Successful migrations require careful planning to meet business needs and maintain data integrity.
By Art Meisler
Data migration is the unglamorous task of a system implementation. …
Article
Technology Innovations Improve Process Chromatography Performance
“We are also seeing that, as regulatory limits impose restrictions for ensuring customer safety, like toxicology and cleaning validation for GMP [good manufacturing practices] environments, off-the-sh…