Search results for "manufacturing" in Articles / App Notes
Article
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…
Article
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…
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Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
Problems can result when changes are made to manufacturing processes. Complexity—in particular, determining which product attributes are most crucial to product quality and patient safety—makes it cha…
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Science Focus Fuels Successful Process Development for Startups
The company first built an inhouse process development group to establish the optimum process, then transferred that final process to a contract manufacturing organization.
SQZ Biotech, after deba…
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Biopharma Says It Has an Evolution in New Technologies and Processes
For example, FDA has been an active proponent of continuous manufacturing for small-molecule drugs. Now that several drugs manufactured via continuous processing have been approved, the interest in th…
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Roadmap Leads to Innovative Biomanufacturing Strategies
The roadmap focuses on biomanufacturing strategy over a 10-year timeframe and defines the needs of, challenges to, and potential solutions for the industry. With a diverse pool of participants from in…