Search results for " manufacturing"
Article
Application of Quality by Design to Viral Safety
Using this approach, products are developed with a thorough understanding of how the raw materials and manufacturing processes impact the eventual clinical performance of the final drug product. QbD f…
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Tools and Processes for Mature and Emerging Therapies
Notable announcements include the application of artificial intelligence to control manufacturing processes, track raw materials, and troubleshoot equipment and process problems via a virtual system. …
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Drug Quality Key to Innovation and Access
Manufacturing challenges
Accelerated FDA approval of important therapies demands drug manufacturing systems able to scale up production quickly and efficiently and to maintain quality throughout th…
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Efforts Accelerate to Streamline Postapproval Change Process
By Jill Wechsler
Frequent revisions and updates in manufacturing processes and operations are routine after a drug comes to market to improve products and systems and ensure reliable supply of hig…
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Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
The threat of a previously unknown zoonosis (disease that can be transmitted from animals to humans) causing fatal harm was a call for biologics producers to implement immediate safeguards in their ma…
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A Q&A on Bioprocessing Trends and Technologies at INTERPHEX 2016
A number of equipment manufacturers announced new bioreactors, fermenters, tanks, and other process-related equipment as the move toward single-use systems in commercial manufacturing moves forward.
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Framing Biopharma Success in 2016
Oversized, inefficient research, development, and manufacturing engines were downsized, or transferred to outsourcing providers.
In 2015, FDA’s Center for Drug Evaluation and Research (CDER) appro…
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Tools for Continuous Bioprocessing Development
Ram
In semiconductor manufacturing, for example, a thorough understanding of process variation allows companies to manufacture circuits with billions of transistors at high yields. These variations…
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Technology Innovations Improve Process Chromatography Performance
By Feliza Mirasol
Selecting an appropriate separation technology for biologic manufacturing is a crucial task in maximizing productivity in downstream bioprocessing. Biomanufacturers consider se…
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Moving PAT from Concept to Reality
In-line, at-line, and on-line
To understand the state of PAT technology development, it is necessary to understand the different types of PAT operations used in biologics manufacturing. In-line se…