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Featured Articles
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Continued Progress In Continuous Processing For Bioproduction
By William G. Whitford, Sr. Market Manager, Thermo Fisher Scientific
It's been years since the FDA articulated, in its PAT (process analytical technology) guidance, the goal of "facilitating continuous processing to improve efficiency." Janet Woodcock, of the Center for Drug Evaluation and Research (CDER), recently commented "continuous manufacturing is going to become a reality." However, despite some early successes in particular unit operations, we have seen little application in biopharm manufacturing.
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Key Considerations When Outsourcing Cell-Culture Medium Development
By Trent Carrier, PD-Direct Services, Steve Gorfien, Director of R&D, Life Technologies, and Brian Griffith, Division Contracts Counsel, Life Technologies
Today, cell-culture media for biological manufacturing represents a sizable market of more than $500 million, but even more impressive is the cumulative value of therapeutic products enabled by these reagents, which totals more than $35 billion. Given the importance of these reagents, major suppliers, drug manufacturers, and other biotech companies continue to make significant investments to improve their cell-culture media platforms.
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Spotlight On Process Development
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One-Touch® Single-Use Systems Capabilities Brochure
Meissner's One-Touch single-use systems portfolio delivers optimized fluid handling to the biopharmaceutical industry.
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Product Brochure: Hygienic Processing
In the world of hygiene, where compactness, smart communication, plant footprint, wash-down, dead legs, cross-contamination, and validation are everyday concerns, Bürkert Fluid Control Systems provides process efficiency and higher yields by offering you unlimited process modularity.
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Ensuring Quality Through Proof Perfection
Royal Paper Box, a manufacturer of folding cartons for the pharmaceutical, biotech, and cosmetic industries, prides itself on its long-standing reputation of customer satisfaction and uncompromising effort in delivering the highest standards of quality.
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Pilot And Process Development Capabilities
Pall offers a range of tangential flow filtration systems from small-scale and process development to full-scale process systems. These include standard systems, such as the Minimate, Centramate Pilot, and Centrasette 5AT Systems, as well as standard and custom- engineered process systems that meet the most stringent control and validation requirements.
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Upcoming Webinar
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The Impact Of Variability In Biopharmaceutical Manufacturing |
Americas: Oct. 25, 2012 2:00pm Eastern — Register
Europe: Oct. 25, 2012 4:00pm CEST — Register
In this webinar, we examine the impact of variability in biopharmaceutical manufacturing. Using real data, we suggest that variability is the single biggest issue facing biopharmaceutical manufacturers today, affecting not only unit operations but the entire supply chain design and management. The presence of significant variability requires systems that can 'sense and respond' in real time, so that issues can be resolved quickly and before they impact product quality. |
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