Search results for " facility" in Articles / App Notes
Article
Drug Quality Key to Innovation and Access
An important initiative involves collecting metrics data from drug makers that give a more precise picture of how reliably a drug facility produces quality products. In late November 2016, FDA revised…
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Advancing Single-Use Technology Through Collaboration
…ale, fully single-use system for the entire commercial production process, such as the manufacturing facility built by Amgen in Singapore (2). Despite all of the benefits to single-use technology, or…
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Mixing dynamics in a large volume single use mixer
Large volume single-use technology mixers can be used for mixing operations throughout the entire bioprocess workflow. Large-volume mixers are mainly required in clinical three-scale and production…
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Single-use technologies in downstream process intensification
When using conventional chromatography solutions, cleaning and cleaning validation consumes a considerable amount of time and facility resources. Cleaning-in-place protocols are performed before, duri…
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Continuous Processing for the Production of Biopharmaceuticals
The key distinguishing features of this facility were uninterrupted and fully automated purification, steady-state operation, and consistent product quality throughout operation time. In addition to e…
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Innovative Therapies Require Modern Manufacturing Systems
FDA, the European Medicines Agency, and other established authorities, moreover, are collaborating more to avoid duplication in drug facility inspections and in the registration of innovative medicine…
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Framing Biopharma Success in 2016
Corporate restructurings, regulatory initiatives, and biosimilars will shape biopharma development in 2016.
By Rita C. Peters
The US biopharmaceutical industry turned a new page in 2015 when…
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Tools for Continuous Bioprocessing Development
In 2008, FDA rejected Genzyme’s application to produce Myozyme in a 2000-liter-scale facility under the same approval authorization given for its 160-liter-scale plant. The FDA ruling stated that the …
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mAbs to Watch in 2016
By Randi Hernandez
Of the 45 new molecular entities and new therapeutic biological products approved by FDA in 2015, nine products were monoclonal antibodies (mAbs). And there may be many more o…
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GMP Challenges for Advanced Therapy Medicinal Products
Finalizing GMP requirements and quality standards for the development, manufacture, and clinical testing of ATMPs in the EU is proving to be a complex task.
By Sean Milmo
A consultation period…